Data / Medical devices / United States / Becton, Dickinson & Co.
Becton, Dickinson & Co.: FDA-registered device maker in Sparks, MD, United States, 237 510(k) clearances and 3 PMA approvals
Becton, Dickinson & Co. is registered with the FDA (registration 1119779) in Sparks, MD, United States. It lists 101 device types. The FDA files 237 510(k) clearances and 3 PMA approvals under its listings, the newest dated May 28, 2026. 117 recall events name it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 1119779
- Address
- 7 Loveton Cir., Sparks, MD, United States, 21152
- Owner or operator
- Becton Dickinson and Company (9922032)
- Roles
- Complaint file establishment, Manufacturer, Manufacturer for export, Repackager or relabeler, Specification developer
- First device listed
- December 29, 1977
- Registered through
- 2027
- Brand names listed
- 241115 - BD Francisella tularensis Antigen, 241116 - BD Francisella tularensis Antisera, 333947 - BD CD117 PerCP-Cy5.5, 333948 - BD CD14 APC-Cy7, 333949 - BD CD33 PE-Cy7, 335804 - BD CD2 PE-Cy7, 335805 - BD CD8 PE-Cy7, 335806 - BD CD16 (B73.1) PE-Cy7 and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance. Newest 100 of 237.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| May 28, 2026 | K260213 | BD BACTEC FXI Culture System | MDB | Substantially Equivalent | BD Diagnostic Systems | accessdata.fda.gov |
| April 2, 2026 | K260184 | Onclarity Self-Collection Kit | SEP | Substantially Equivalent | Becton, Dickinson and Company | accessdata.fda.gov |
| October 31, 2025 | K250358 | BD Enteric Bacterial Panel for BD COR System, BD Enteric Bacterial Panel plus for BD COR System, and Enteric Bacterial Panel Diluent for BD COR System | PCI | Substantially Equivalent | Becton, Dickinson and Company | accessdata.fda.gov |
| August 8, 2025 | K251713 | BD Phoenix Automated Microbiology System - GN Eravacycline (0.125-2 µg/mL) | LON | Substantially Equivalent | Becton, Dickinson and Company | accessdata.fda.gov |
| June 16, 2025 | K243872 | BD Veritor System for SARS-CoV-2 | QVF | Substantially Equivalent | Becton, Dickinson and Company | accessdata.fda.gov |
| May 19, 2025 | K250447 | BD Phoenix Automated Microbiology System - GN Imipenem-relebactam (0.0625/4 - 16/4 µg/mL) | LON | Substantially Equivalent | Becton, Dickinson and Company | accessdata.fda.gov |
| April 22, 2025 | K243343 | BD CTGCTV2 | QEP | Substantially Equivalent | Bd Integrated Diagnostic Solutions/Becton, | accessdata.fda.gov |
| March 6, 2025 | K250344 | BD Phoenix Automated Microbiology System | LON | Substantially Equivalent | Becton, Dickinson and Company | accessdata.fda.gov |
| March 15, 2024 | K233986 | BD Phoenix Automated Microbiology System - GN Ciprofloxacin (0.01564 µg/mL) | LON | Substantially Equivalent | Becton, Dickinson and Company | accessdata.fda.gov |
| December 5, 2023 | K232434 | BD Veritor System for Rapid Detection of Flu A+B CLIA Waived Kit | PSZ | Substantially Equivalent | Bd | accessdata.fda.gov |
| August 31, 2023 | K222563 | BD Kiestra IdentifA | QQV | Substantially Equivalent | Becton, Dickinson and Company | accessdata.fda.gov |
| July 31, 2023 | K230956 | BD Respiratory Viral Panel for BD MAX System; BD Respiratory Viral Panel-SCV2 for BD MAX System | QOF | Substantially Equivalent | Bd Integrated Diagnostic Solutions / | accessdata.fda.gov |
| May 4, 2023 | K213280 | BD Kiestra Methicillin-resistant Staphylococcus aureus (MRSA) Application, BD Kiestra MRSA App | QQY | Substantially Equivalent | Bd Kiestra B.V. | accessdata.fda.gov |
| March 24, 2023 | K222591 | BD BACTEC Plus Aerobic/F Culture Vials | MDB | Substantially Equivalent | Becton, Dickinson and Company | accessdata.fda.gov |
| March 24, 2023 | K222559 | BD BACTEC Myco/F Lytic Culture Vials | MDB | Substantially Equivalent | Becton, Dickinson and Company | accessdata.fda.gov |
| March 6, 2023 | K223653 | BD Vaginal Panel | PQA | Substantially Equivalent | Becton, Dickinson and Company | accessdata.fda.gov |
| January 27, 2023 | K223016 | BD VeritorTM System for Rapid Detection of Flu A+B CLIA-Waived Kit | PSZ | Substantially Equivalent | Bd | accessdata.fda.gov |
| December 21, 2022 | K221826 | BD BBL Sensi-Disc Cefiderocol 30ug (FDC-30) | JTN | Substantially Equivalent | Becton, Dickinson and Company | accessdata.fda.gov |
| September 21, 2022 | K220607 | BD MAX Enteric Viral Panel | PCH | Substantially Equivalent | Becton, Dickinson and Company | accessdata.fda.gov |
| August 19, 2022 | K220193 | BD MAX Enteric Parasite Panel | PCH | Substantially Equivalent | Becton, Dickinson and Company | accessdata.fda.gov |
| July 28, 2022 | K214122 | BD MAX Enteric Bacterial Panel, BD MAX Extended Enteric Bacterial Panel | PCI | Substantially Equivalent | Becton, Dickinson and Company | accessdata.fda.gov |
| May 10, 2022 | K210585 | BD CTGCTV2 | QEP | Substantially Equivalent | Becton, Dickinson and Company | accessdata.fda.gov |
| November 3, 2021 | K191964 | BD Kiestra IdentifA | QQV | Substantially Equivalent | Becton, Dickinson and Company | accessdata.fda.gov |
| October 18, 2021 | K201017 | BD MAX Vaginal Panel, BD MAX System, BD Molecular Swab Collection Kit | PQA | Substantially Equivalent | Geneohm Sciences Canada, Inc. (Bd Life Sciences) | accessdata.fda.gov |
| October 21, 2019 | K191957 | BD MAX Vaginal Panel | PQA | Substantially Equivalent | Geneohm Sciences Canada, Inc. (Bd Diagnostics) | accessdata.fda.gov |
| August 29, 2019 | K190613 | BD MAX Check-Points CPO | POC | Substantially Equivalent | Check-Points Health B.V. | accessdata.fda.gov |
| July 1, 2019 | K190905 | BD Phoenix Automated Microbiology System GN Ceftaroline (0.0156-4 µg/mL) | LON | Substantially Equivalent | Becton, Dickinson and Company | accessdata.fda.gov |
| January 8, 2019 | K182692 | BD MAX CTGCTV2, BD MAX System | OUY | Substantially Equivalent | Becton, Dickinson and Company | accessdata.fda.gov |
| November 29, 2018 | K181427 | BD MAX Enteric Viral Panel, BD MAX Instrument | PCH | Substantially Equivalent | Becton, Dickinson and Company | accessdata.fda.gov |
| September 21, 2018 | K181665 | BD Phoenix Automated Microbiology System - BD Phoenix CPO detect - GN | LON | Substantially Equivalent | Becton, Dickinson and Company | accessdata.fda.gov |
| March 20, 2018 | K180438 | BD Veritor System for Rapid Detection of Flu A + B CLIA waived kit | PSZ | Substantially Equivalent | Bd | accessdata.fda.gov |
| March 16, 2018 | K173873 | BD BACTEC Peds Plus/F Culture Vials Soybean-Casein Digest Broth with Resins in a Plastic Vial | MDB | Substantially Equivalent | Becton, Dickinson and Company | accessdata.fda.gov |
| February 9, 2018 | K173523 | BD Phoenix Automated Microbiology System - GN Meropenem-vaborbactam (0.125/8-32/8 ug/mL) | LON | Substantially Equivalent | Becton, Dickinson and Company | accessdata.fda.gov |
| January 5, 2018 | K173252 | BD Phoenix Automated Microbiology System - GN Ceftolozane/tazobactam (0.25/4-32/4 ug/mL) | LON | Substantially Equivalent | Becton, Dickinson and Company | accessdata.fda.gov |
| May 2, 2017 | K170308 | BD MAX Extended Enteric Bacterial Panel, BD MAX System | PCH | Substantially Equivalent | Becton, Dickinson and Company | accessdata.fda.gov |
| March 21, 2017 | K163637 | BD Phoenix Automated Microbiology System - GN Ceftazidime/avibactam (0.25/4- 32/4ug/mL) | LON | Substantially Equivalent | Becton Dickinson & Company | accessdata.fda.gov |
| February 9, 2017 | K161810 | BD BACTEC Standard/10 Aerobic/F Culture Vials Soybean-Casein Digest Broth in a Plastic Vial | MDB | Substantially Equivalent | Becton Dickinson | accessdata.fda.gov |
| October 28, 2016 | DEN160001 | BD MAX Vaginal Panel, BD MAX Instrument | PQA | Unknown | Geneohm Sciences Canada, Inc. (Bd Diagnostics) | accessdata.fda.gov |
| August 8, 2016 | K161306 | BD BACTEC Standard Anaerobic/F Culture Vials Soybean-Casein Digest Broth in a Plastic Vial | MDB | Substantially Equivalent | Becton Dickinson | accessdata.fda.gov |
| February 25, 2016 | K160164 | BD Veritor System for Rapid Detection of Flu A + B Labratory Kit | PSZ | Substantially Equivalent | Becton, Dickinson & CO | accessdata.fda.gov |
| February 25, 2016 | K151866 | BD BACTEC Peds Plus/F Culture Vials (plastic) | MDB | Substantially Equivalent | Becton, Dickinson and Company | accessdata.fda.gov |
| February 24, 2016 | K160161 | BD Veritor System for Rapid Detection of Flu A + B CLIA waived kit | PSZ | Substantially Equivalent | Becton, Dickinson & CO | accessdata.fda.gov |
| January 15, 2016 | K151320 | BD Phoenix Automated Microbiology System-Ertapenem 0.0625-8 mcg/ml | LON | Substantially Equivalent | Becton, Dickinson and Company | accessdata.fda.gov |
| October 27, 2015 | K152874 | BD Veritor System for the Rapid Detection of Flu A + B Laboratory kit | PSZ | Substantially Equivalent | Becton, Dickinson and Co. | accessdata.fda.gov |
| October 27, 2015 | K152870 | BD Veritor System for the Rapid Detection of Flu A + B CLIA waived kit | PSZ | Substantially Equivalent | Becton, Dickinson and Co. | accessdata.fda.gov |
| October 13, 2015 | K152516 | BD BBL Sensi-Disc Ceftazidime Avibactam (30/20ug), Antimicrobial Susceptibility Test Disks | JTN | Substantially Equivalent | Becton, Dickinson and Company | accessdata.fda.gov |
| August 25, 2015 | K143648 | BD MAX Enteric Parasite Panel, BD MAX Instrument | PCH | Substantially Equivalent | Becton, Dickinson and Company | accessdata.fda.gov |
| June 10, 2015 | K151291 | BD Veritor (TM) System for the Rapid Detection of Flu A+B | PSZ | Substantially Equivalent | Becton, Dickinson and Company | accessdata.fda.gov |
| June 8, 2015 | K151301 | BD Veritor System Flu A+B Assay | PSZ | Substantially Equivalent | Becton, Dickinson and Company | accessdata.fda.gov |
| December 10, 2014 | K141810 | BD BACTEC PLUS ANAEROBIC/F (PLASTIC) | MDB | Substantially Equivalent | Becton, Dickinson and Company | accessdata.fda.gov |
| October 28, 2014 | K142170 | BD PHOENIX AUTOMATED MICROBIOLOGY SYSTESM - TIGECYCLINE (0.313-4UG/ML) GP | LON | Substantially Equivalent | Becton, Dickinson and Company | accessdata.fda.gov |
| June 2, 2014 | K140468 | BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFTAROLINE (0.625-4 UG/ML) | LON | Substantially Equivalent | Becton, Dickinson and Company | accessdata.fda.gov |
| May 20, 2014 | K140448 | BD PROBETEC NEISSERIA GONORRHOEAE (GC) QX AMPLIFIED DNA ASSAY | LSL | Substantially Equivalent | Becton, Dickinson & CO | accessdata.fda.gov |
| May 20, 2014 | K140447 | BD VIPER LT SYSTEM | OOI | Substantially Equivalent | Becton, Dickinson and Company | accessdata.fda.gov |
| May 20, 2014 | K140446 | BD PROBETEC CHLAMYDIA TRACHOMATIS (CT) QX AMPLIFIED DNA ASSAY | MKZ | Substantially Equivalent | Becton, Dickinson & CO | accessdata.fda.gov |
| May 6, 2014 | K140111 | BD MAX(TM) ENTERIC BACTERIAL PANEL;BD MAX(TM) INSTRUMENT | PCI | Substantially Equivalent | Becton, Dickinson and Company | accessdata.fda.gov |
| February 14, 2014 | K132909 | BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM TIGECYCLINE (0.25-16 UG/ML) | LON | Substantially Equivalent | Becton, Dickinson and Company | accessdata.fda.gov |
| December 27, 2013 | K132674 | BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM- MEROPENEM (0.125-32 UG/ML) | LON | Substantially Equivalent | Becton, Dickinson and Company | accessdata.fda.gov |
| December 20, 2013 | K133605 | BD MAX MRSA XT, BD MAX INSTRUMENT | NQX | Substantially Equivalent | Geneohm Sciences Canada, Inc. | accessdata.fda.gov |
| November 26, 2013 | K132822 | BD MAX STAPHSR ASSAY, INSTRUMENT | NQX | Substantially Equivalent | Geneohm Sciences Canada, Inc. (Bd Diagnostics) | accessdata.fda.gov |
| November 15, 2013 | K133140 | BD VERITOR SYSTEM FOR THE RAPID DETECTION OF RSV | GQG | Substantially Equivalent | Becton, Dickinson & CO | accessdata.fda.gov |
| November 13, 2013 | K133138 | BD Veritor System Flu A+B Assay | PSZ | Substantially Equivalent | Becton, Dickinson & CO | accessdata.fda.gov |
| November 7, 2013 | K132456 | BD VERITOR (TM) SYSTEM FOR RAPID DETECTION OF RSV | GQG | Substantially Equivalent | Becton, Dickinson and Company | accessdata.fda.gov |
| October 2, 2013 | K132693 | BD Veritor System Flu A+B Assay | PSZ | Substantially Equivalent | Becton, Dickinson and Company | accessdata.fda.gov |
| September 23, 2013 | K132692 | BD VERITOR SYSTEM FOR THE RAPID DETECTION OF FLU A+B | PSZ | Substantially Equivalent | Becton, Dickinson and Company | accessdata.fda.gov |
| August 7, 2013 | K132259 | BD VERITOR SYSTEM FOR THE RAPID DETECTION OF FLU A+B | PSZ | Substantially Equivalent | Becton, Dickinson and Company | accessdata.fda.gov |
| August 7, 2013 | K132256 | BD VERITOR SYSTEM FOR THE RAPID DETECTION OF FLU A+B | PSZ | Substantially Equivalent | Becton, Dickinson and Company | accessdata.fda.gov |
| July 10, 2013 | K131331 | BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - VANCOMYCIN (0.5-32 UG/ML) | LON | Substantially Equivalent | Becton, Dickinson & CO | accessdata.fda.gov |
| June 27, 2013 | K123404 | BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM- IMIPENEM (0.0625-32 UG/ML) | LON | Substantially Equivalent | Becton, Dickinson & CO | accessdata.fda.gov |
| June 26, 2013 | K123266 | BD PHOENIX AUTOMATED MICROIOLOGY SYSTEM- ERTAPENEM 0.0625-8 UG/ML-GN | LON | Substantially Equivalent | Becton, Dickinson and Company | accessdata.fda.gov |
| May 13, 2013 | K123903 | BACTEC Lytic/10 Anaerobic/F Culture Vials (plastic) | MDB | Substantially Equivalent | Becton, Dickinson & CO | accessdata.fda.gov |
| April 2, 2013 | K130470 | BD MAX CDIFF ASSAY, BD MAX INSTRUMENT | OZN | Substantially Equivalent | Geneohm Sciences Canada, Inc. (Bd Diagnostics) | accessdata.fda.gov |
| February 6, 2013 | K122718 | BD VERITOR(TM) SYSTEM FOR RAPID DETECTION OF GROUP A STREP | GTY | Substantially Equivalent | Becton, Dickinson and Company | accessdata.fda.gov |
| September 18, 2012 | K121633 | BD VERITOR(TM) SYSTEM FOR THE RAPID DETECTION OF RSV | GQG | Substantially Equivalent | Becton, Dickinson and Company | accessdata.fda.gov |
| September 7, 2012 | K121797 | BD VERITOR(TM) SYSTEM FOR RAPID DETECTION OF FLU A+B | PSZ | Substantially Equivalent | Becton, Dickinson and Company | accessdata.fda.gov |
| March 23, 2012 | K120049 | BD VERITOR SYSTEM FOR THE RAPID DETECTION OF FLU A+B | PSZ | Substantially Equivalent | Becton, Dickinson and Company | accessdata.fda.gov |
| March 16, 2012 | K113558 | BD BACTEC Plus Aerobic/F Culture Vials (plastic) | MDB | Substantially Equivalent | Becton, Dickinson and Company | accessdata.fda.gov |
| February 16, 2012 | K111860 | BD MAX GBS ASSAY, BD MAX INSTRUMENT | NJR | Substantially Equivalent | Becton, Dickinson & CO | accessdata.fda.gov |
| October 28, 2011 | K112277 | BD VERITOR(TM) SYSTEM FOR RAPID DETECTION OF FLU A+B | PSZ | Substantially Equivalent | Becton, Dickinson and Company | accessdata.fda.gov |
| October 18, 2011 | K112586 | CEFTAROLINE 30 MICROGRAMS, BBL(TM) SENSI-DISC(TM) | JTN | Substantially Equivalent | Becton, Dickinson and Company (BD) | accessdata.fda.gov |
| August 20, 2010 | K092767 | BBL CHROMAGAR MRSA II | JSO | Substantially Equivalent | Becton, Dickinson & CO | accessdata.fda.gov |
| November 13, 2009 | K091730 | BD PROBETEC NEISSERIA GONORRHOEAE (GC) QX AMPLIFIED DNA ASSAY | LSL | Substantially Equivalent | Becton, Dickinson & CO | accessdata.fda.gov |
| November 13, 2009 | K091724 | BD PROBETEC CHLAMYDIA TRACHOMATIS (CT) Q AMPLIFIED DNA ASSAY | MKZ | Substantially Equivalent | Becton, Dickinson & CO | accessdata.fda.gov |
| June 2, 2009 | K090824 | BD PROBETEC CHLAMYDIA TRACHOMATIS (CT) QX AMPLIFIED DNA ASSAY | MKZ | Substantially Equivalent | Becton, Dickinson & CO | accessdata.fda.gov |
| May 27, 2009 | K090827 | BD PROBETEC NEISSERIA GONORRHOEAE (GC) QX AMPLIFIED DNA ASSAY | LSL | Substantially Equivalent | Becton, Dickinson & CO | accessdata.fda.gov |
| January 29, 2009 | K082852 | BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-NITROFURANTOIN (GP) 4-128 UG/ML | LON | Substantially Equivalent | Becton, Dickinson & CO | accessdata.fda.gov |
| December 11, 2008 | K081825 | BD PROBETEC NEISSERIA GONORRHOEAE (GC) Q AMPLIFIED DNA ASSAY | LSL | Substantially Equivalent | Becton, Dickinson & CO | accessdata.fda.gov |
| December 5, 2008 | K082913 | BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-DOXYCYCLINE (GP) 0.25-16 UG/ML | LON | Substantially Equivalent | Becton, Dickinson & CO | accessdata.fda.gov |
| November 20, 2008 | K082538 | BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-PHOENIX INDUCIBLE MACROLIDE RESISTANCE TEST | LON | Substantially Equivalent | Becton, Dickinson & CO | accessdata.fda.gov |
| May 12, 2008 | K080998 | DORIPENEM 10UG BBL SENSI-DISC | JTN | Substantially Equivalent | Becton, Dickinson & CO | accessdata.fda.gov |
| November 20, 2007 | K070691 | BBL CHROMAGAR 0157 | JSI | Substantially Equivalent | Becton, Dickinson & CO | accessdata.fda.gov |
| September 24, 2007 | K070809 | BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-MINOCYCLINE (GP) 1-32 UG/ML | LON | Substantially Equivalent | Becton, Dickinson & CO | accessdata.fda.gov |
| August 20, 2007 | K071623 | BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM, AMPICILLIN-SULBACTAM (GN) 1/0.5-32/16 UG/ML | LON | Substantially Equivalent | Becton, Dickinson & CO | accessdata.fda.gov |
| March 7, 2007 | K063486 | BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM MINOCYCLINE (1-32 UG/ML) GRAM NEGATIVE ID/AST OR AST ONLY | LON | Substantially Equivalent | Becton, Dickinson & CO | accessdata.fda.gov |
| February 14, 2007 | K063824 | BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - AZTREONAM (GN) 0.5-64UG/ML | LON | Substantially Equivalent | Becton, Dickinson & CO | accessdata.fda.gov |
| February 9, 2007 | K063811 | BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFAZOLIN (GN) 0.5-32UG/ML | LON | Substantially Equivalent | Becton, Dickinson & CO | accessdata.fda.gov |
| January 11, 2007 | K063573 | BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-CEFTAZIDIME (GN) 0.5-64 UG/ML | LON | Substantially Equivalent | Becton, Dickinson & CO | accessdata.fda.gov |
| December 8, 2006 | K063301 | BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFEPIME (GN) 0.5-64UG/ML | LON | Substantially Equivalent | Becton, Dickinson & CO | accessdata.fda.gov |
| November 21, 2006 | K062945 | BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - ERTAPENEM (GN) 0.25-32 UG/ML | LON | Substantially Equivalent | Becton, Dickinson & CO | accessdata.fda.gov |
| November 15, 2006 | K062944 | BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFTRIAXONE (GN) 0.5-64UG/ML | LON | Substantially Equivalent | Becton, Dickinson & CO | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| February 12, 2018 | P160037 | BD ONCLARITY HPV ASSAY | MAQ | 28 | August 19, 2026 | accessdata.fda.gov |
| June 17, 1999 | P970018 | BD PREPSTAIN SYSTEM | MKQ | 36 | September 6, 2024 | accessdata.fda.gov |
| September 29, 1995 | P950009 | AUTOPAP(R) 300 QC AUTOMATIC PAP SCREENER/QC SYSTEM | MNM | 24 | July 11, 2022 | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI. Newest 100 of 117.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| August 13, 2026 | 99725 | Class II | Ongoing | BD Phoenix Panel NMIC-312. Catalog Number: 449082. | Potential for quality control failures with Klebsiella pneumoniae ATCC BAA-1705 when using the CPO Ambler classification feature. | accessdata.fda.gov |
| April 7, 2026 | 98657 | Class II | Ongoing | BD GasPak EZ CO2 Pouch System. Catalog Number: 260684. for microbiologic use | BD identified an issue affecting certain lots of BD GasPak EZ CO2 and BD GasPak EZ Campy Gas Generating Pouch Systems, where gas generating sachets may produce carbon dioxide levels below specification. | accessdata.fda.gov |
| October 23, 2025 | 97817 | Class II | Ongoing | BD Kiestra" Isolate Suspension Cuvette Array; Catalog No.: 246100 | The 2D barcodes on these cuvettes contain formatting errors that prevent the analyzing system from correctly reading the expiration date. As a result, the instrument enters an error state and the cuvettes cannot be used. | accessdata.fda.gov |
| September 23, 2025 | 97479 | Class II | Ongoing | BD EpiCenter Microbiology Data Management System, labeled as the following: 1. Computer System Epicenter F/G, Catalog Number: 441002. 2. COMPUTER OPTIPLEX EPICENTER SPARE, Catalog Number: 441421. 3. Generic NUC 2, Catalo | Product service credentials used by some BD technical support teams to access certain BD products were accessed by an unauthorized actor. Until these product service credentials are updated, there is a risk of unauthorized access that may impact the confidentiality, integrity and/or availability of the relevant products and associated data. | accessdata.fda.gov |
| June 23, 2025 | 97142 | Class II | Ongoing | BD COR System Software. Model Number: 444829. | Potential for functionality issue that supports the Over labeling feature and could lead to possible false negative results. | accessdata.fda.gov |
| May 20, 2025 | 96910 | Class II | Ongoing | BD BACTEC MGIT 960 PZA Kit. IVD qualitative procedure for susceptibility testing of Mycobacterium tuberculosis, from culture to pyrazinamide (PZA). | BD has received additional complaints of intermittent false resistance results for PZA during susceptibility testing of Mycobacterium tuberculosis isolates. | accessdata.fda.gov |
| February 12, 2025 | 96244 | Class II | Ongoing | BD BBL TB Stain Kit K, Catalog (REF): 212522 | One component of the kit was shipped with an expiration date of 30Sep2024 while the Certificate of Analysis (COA) indicated an expiration date of 30Apr2025. | accessdata.fda.gov |
| December 19, 2024 | 95963 | Class II | Ongoing | BD PCR Cartridges used with MAX System. Model Number: 437519 | Potential for signal drift in specific lots of BD PCR Cartridges. | accessdata.fda.gov |
| November 6, 2024 | 95646 | Class II | Ongoing | BD BBL Sensi Disc Ampicillin 2 g (AM-2) - In-Vitro BD BBL Sensi Disc Ampicillin 2 g (AM-2) are used for semi-quantitative in vitro susceptibility testing by the agar disc diffusion test procedure of common, rapidly growi | BD identified through potency testing as part of a stability test request to monitor Ampicillin AM-2 due to decrease in potency results of 65% at 18 months, may result in falsely resistant result for ampicillin susceptibility | accessdata.fda.gov |
| October 31, 2024 | 95636 | Class II | Ongoing | BD EpiCenter Single User Software Version or Model: 441007 Catalog Number: 441007 | BD confirmed that product service credentials used by some BD technical support teams to access certain BD products were accessed by an unauthorized actor. Until these product service credentials are updated, there is a risk of unauthorized access that may impact the confidentiality, integrity and/or availability of the relevant products and associated data. | accessdata.fda.gov |
| September 12, 2024 | 95394 | Class II | Ongoing | BD Synapsys Informatics Solution with software versions: 4.20, 4.30, 5.10, 5.20 and 5.30- IVD standalone laboratory software solution providing data management and workflow management functionality across locations where | Synapsys software versions 4.20, 4.30, 5.10, 5.20, or 5.30 and utilizing the in-line breakpoint feature, an error is occurring where BD Synapsys will incorrectly display breakpoints for organisms that do not have defined breakpoints in CLSI or EUCAST. This occurs when the identified organism is included in the same interpretive group as a species for which t | accessdata.fda.gov |
| August 1, 2024 | 95145 | Class II | Ongoing | BD Phoenix M50 instrument -Intended for the rapid identification (ID) and antimicrobial susceptibility testing (AST) of clinically significant bacteria. The BD Phoenix System provides rapid results for most aerobic and f | Escherichia coli (E. coli) misidentification for clinical samples that were tested on BD Phoenix" M50 instrument and BD Phoenix" 100, may lead to misdiagnosis and inappropriate treatment of infections caused by E. coli | accessdata.fda.gov |
| July 18, 2024 | 95023 | Class II | Ongoing | BD BACTEC MGIT 960 PZA Kit)- IVD qualitative procedure for susceptibility testing of Mycobacterium tuberculosis, from culture to pyrazinamide (PZA) Catalog Number: 245128 | May intermittently produce falsely resistant results for pyrazinamide (PZA) during susceptibility testing of Mycobacterium tuberculosis isolates. | accessdata.fda.gov |
| July 9, 2024 | 94965 | Class II | Ongoing | BD Kiestra Urine Culture Application Powered by BD Synapsys Informatics Solution; Catalog (Ref): 444900 | There is a potential risk that the image colony count does not adequately reflect the actual plate colony count and may lead to inaccurate counts that would impact patient diagnosis and subsequent care. | accessdata.fda.gov |
| May 7, 2024 | 94599 | Class II | Ongoing | BD SARS-CoV-2 Reagents for BD MAX" Systems. RT-PCR test to detect SARS-CoV-2 in nasal, nasopharyngeal, oropharyngeal swab specimens, and saliva specimens. | Assays may produce false negative results due to decreased activity of the enzyme utilized in manufacturing. | accessdata.fda.gov |
| February 29, 2024 | 94180 | Class II | Ongoing | BD Phoenix NMIC-306 Panel is a self-inoculating (when used with a BD Phoenix Automated Microbiology System) polystyrene panel (tray) containing control wells and substrate wells with dried biochemical substrates that use | Products were found to have confirmed drug cross contamination prior to release may lead to incorrect, inadequate, or absent antibiotic treatment or delay in results | accessdata.fda.gov |
| January 8, 2024 | 93789 | Class II | Ongoing | Sensi Disc Amoxicillin with Clavulanic Acid 20/10 g, Catalog No. 231628 and 231629. These discs are used for semi-quantitative in vitro susceptibility testing | There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibility testing (AST) for H. influenzae. This may cause product discard, delayed results, or additional adverse diagnostic outcomes, such as a delay in diagnosis, the selection of inappropriate antibiotics, or extended duration of antibiotic exposure and the treatmen | accessdata.fda.gov |
| September 12, 2023 | 93097 | Class II | Ongoing | BD BACTEC Plus Aerobic/F Culture Vials, Catalog Number 442023 | Certain vials of the BD BACTEC" Plus Aerobic/F Culture Vials have a labeling issue where duplicate barcode sequence numbers have been identified on more than one vial. | accessdata.fda.gov |
| June 8, 2023 | 92406 | Class II | Ongoing | BD Synapsys Informatics Solution, Catalog Number 444150 | There is a risk of mis-association of patient demographic data for users who choose to report results manually when their Service Control Unit (SCU) is operating near capacity and are using save actions (Skip, Final Discard, Mark as Read, Save) to process patient results rapidly. | accessdata.fda.gov |
| May 1, 2023 | 92293 | Class II | Ongoing | BD Veritor System for Rapid Detection of SARS-CoV-2 & Flu A+B, 30 Single Use Test Devices- Intended for the in vitro, simultaneous qualitative detection and differentiation of SARS-CoV-2 nucleocapsid antigen and influenz | IFU- Instructions for Use (IFU) package insert and both the IFU packaged with the test kit and the electronic version on the BD website not approved by FDA,specifically describing specimen type, could cause use of the test with invalid specimen types, which may produce false positive or false negative results.Erroneous results can cause a delay in diagnosis | accessdata.fda.gov |
| March 22, 2023 | 91937 | Class II | Ongoing | BD Kiestra InoqulA+ with BD Kiestra" InoqulA+" and BeA Software version 5.1 and 5.1.1 as part of the Icefall A platform. An in vitro diagnostic medical device intended to automate specimen processing according to user-de | Upon installation of BD Kiestra" InoqulA+" and BeA version 5.1 and 5.1.1 as part of the Icefall A platform, plate information was not visible in Synapsys" after processing has occurred. This could possibly lead to a delayed diagnosis and/or treatment or need for specimen recollection streaking plated media, and inoculating tubes and slides. In Semi-Automated | accessdata.fda.gov |
| November 21, 2022 | 91201 | Class II | Ongoing | BBL Chocolate II Agar- IVD for the isolation and cultivation of Neisseria species. Catalog (Ref) Number: 221267 | Boxes contain a reduced concentration of Nicotinamide Adenine Dinucleotide and does not provide enough of the blood factors necessary to support Haemophilus growth. The reduction could cause a false negative result for Haemophilus isolation in a clinical specimen. | accessdata.fda.gov |
| October 13, 2022 | 91010 | Class II | Ongoing | BD Phoenix PMIC/ID-107: The Phoenix PMIC/ID panel is used for the rapid identification and susceptibility of most aerobic and facultative anaerobic gram-positive bacteria of human origin with selected antimicrobial agent | Misformulated minocycline-can cause erroneously increased Minimal Inhibitory Concentration (MIC) values when performing antibiotic susceptibility testing (AST) against minocycline and result in the reporting of false resistance for clinical samples if the initial Quality Control (QC) testing of the panel batch passes, delaying treatment of the patient with t | accessdata.fda.gov |
| March 9, 2022 | 89896 | Class II | Terminated | BD Synapsys Microbiology Informatics Solution, Catalog Number 444150, Software Version 4.10 | When updating BD Kiestra customers to BD Synapsys version 4.10, the custom antibiotic codes set by the customer are overwritten with the BD default antibiotic codes. | accessdata.fda.gov |
| January 5, 2022 | 89358 | Class II | Ongoing | BD Veritor Plus Analyzer - intended to provide rapid test results in near-patient settings. Catalog Number: 256066 | May have the potential to overheat and/or cause fire, the issue can occur when an unauthorized alternative AC power adapter, and not the one provided by BD is used to power the instrument. | accessdata.fda.gov |
| March 24, 2021 | 87605 | Class II | Terminated | BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal specimens Catalog Number: 444213 | BioGX SARS-CoV-2 Reagents for BD MAX" System rehydration buffer tubes were not adequately sealed causing some tubes to be partially filled or empty upon use. A partially filled or empty rehydration buffer tube may lead to an Unresolved (UNR) result on the BD MAX" System | accessdata.fda.gov |
| March 17, 2021 | 87546 | Class II | Terminated | BD BBL Martin-Lewis Agar, 100 Ea - Product Usage: used for the isolation of pathogenic Neisseria from specimens containing mixed flora of bacteria and fungi. Catalog Number: 221558 | Products show heavy growth of C. albicans after 24 hours of incubation due to misformulation (expected reaction is partial inhibition after 18-48 hours incubation) and reduce the identification of Neisseria contributing to a delay in time to definitive diagnosis or a delay in proper treatment | accessdata.fda.gov |
| January 7, 2021 | 87178 | Class II | Terminated | BioGX SARS-CoV-2 Reagents for BD MAX System Catalog number (REF) 444213. In vitro diagnostic. SARS-CoV-2 Reagents is a real-time RT-PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in n | Some N1 and N2 master mix pouches packaged within the lots of BioGX SARS-CoV-2 Reagents for BD MAX System may be mislabeled. This could result in a kit containing two pouches of N1 master mix or two pouches of N2 master mix, instead of one pouch of each. If laboratory personnel do not notice that both pouches contain tubes with the same color foil seal and u | accessdata.fda.gov |
| December 8, 2020 | 86963 | Class II | Terminated | BD Phoenix PMIC/ID-105: IVD is intended for the in vitro rapid identification (ID) of gram-positive bacteria from pure culture belonging to the genera Staphylococcus, Enterococcus, and other gram-positive cocci and gram- | BD Phoenix Sulfamethoxazole-trimethoprim (SXT) Resistance, false resistant SXT result with S. aureus could lead to a potential loss of access to a preferred antibiotic regimen and potential reduction in effectiveness of treatment of the infection | accessdata.fda.gov |
| July 20, 2020 | 86061 | Class II | Terminated | BD MAX SARS-CoV-2 Reagents, Cat. No. 445003 (UDI 00382904450038) and 445003-01 (UDI (01)603829044500301) - Product Usage: intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal, nasa | BD is experiencing elevated rates of potential false positive results from certain customers when using the BD SARS-CoV-2 Reagents for the BD MAX System. False positive test results could lead to a delay in diagnosis and potentially cause the patient to be exposed to COVID-19 if they are isolated with an infected individual. | accessdata.fda.gov |
| April 14, 2020 | 85508 | Class II | Terminated | BD BBLTM Gram Crystal Violet 250mL-- IVD Primary stain for Staining Microorganisms, Catalog Number: 212525 - Product Usage: Gram Stain Kits and Reagents are used to stain microorganisms from cultures or specimens by the | May exhibit increased levels of artifacts which could be difficult to distinguish from gram positive cocci, increased levels of artifacts could result in a false-positive Gram stain | accessdata.fda.gov |
| July 26, 2019 | 83513 | Class II | Terminated | BD Kiestra InoqulA Software Version 20.3.IVD automated specimen processing Catalog Number: 447202 | An anomaly is present in InoqulA / InoqulA+ software version 20.3, has the potential to cause a mismatch between a specimen and plate | accessdata.fda.gov |
| July 17, 2019 | 83406 | Class II | Terminated | Kit BD Max Check-Points CPO IVD EU; Catalog # 278102 | The foil bags containing extraction tubes for BD MAX" Reagent products may not been sealed properly. | accessdata.fda.gov |
| April 3, 2019 | 82616 | Class II | Terminated | BD Veritor Plus Analyzer- In-Vitro Diagnostic intended to use with the BD Veritor System Test Devices. Catalog Number: 256066 | Background calibration has the potential to cause false positive or false negative test results. An incorrect test result with the BD Veritor System could lead to possible misdiagnosis and inappropriate treatment | accessdata.fda.gov |
| February 21, 2019 | 82225 | Class II | Terminated | BD Synapsys Laboratory Solutions Catalog Number:444150 Product Usage: BD Synapsys is a laboratory software solution providing data management and workflow management functionality across clinical diagnostic activities. T | BD Synapsys version 2.1 allowed the potential for a test order to be associated to an incorrect culture record. | accessdata.fda.gov |
| January 14, 2019 | 82046 | Class II | Terminated | BD MAX Enteric Bacterial Panel -For In Vitro Diagnostic Use with the BD MAX System Catalog Number: 442963 The BD MAX Enteric Bacterial Panel performed on the BD MAX System is an automated in vitro diagnostic test for the | False negative results with the BD MAX Extended Enteric Bacterial Panel when testing specifically for Enterotoxigenic Escherichia coli (ETEC) and Plesiomonas shigelloides targets of the BD MAX Extended Enteric Bacterial Panel assay. | accessdata.fda.gov |
| December 20, 2018 | 81952 | Class II | Terminated | Phoenix AST-s Indicator, Catalog Number 246009 | Panels inoculated using certain lots of the indicator solution are demonstrating an increased occurrence of test aborts. | accessdata.fda.gov |
| October 22, 2018 | 81572 | Class II | Terminated | BD BBL Trypticase Soy Agar with 5% Sheep Blood, Catalog No. 221261, (non-selective, non-differential) | a portion of a single lot was not manufactured in accordance with the internal formulation resulting in inhibited growth of Gram negative organisms. | accessdata.fda.gov |
| September 24, 2018 | 81145 | Class II | Terminated | BD Max Instrument Reader Spare Part, Catalog Number 8090369/443364, 44336409 (Repaired Reader spare part) - Product Usage: The BD MAX System, used in conjunction with appropriate extraction kits and reagents, is capable | A trend for false positive Candida glabrata results has been confirmed. The discrepant results impact the Candida glabrata target only, when in the presence of a Trichomonas vaginalis true positive. | accessdata.fda.gov |
| September 21, 2018 | 81097 | Class III | Terminated | BD FocalPoint Slide Profiler and BD FocalPoint GS Review Station; Catalog Nos. 490398, 490653, 491085, 491086, 491090, 490189 The BD FocalPoint GS Imaging System is intended to assist in cervical cancer screening of BD S | The device may not function at the lower end (<15 deg. C) of the labeled operating temperatures. The instrument returns to normal operating conditions when environmental temperatures are at or above 15 deg. C. This issue has no potential to cause harm to either the patient or the operator. At the lower temperature, the instrument may fail to initialize, in w | accessdata.fda.gov |
| June 21, 2018 | 80573 | Class II | Terminated | BD BBL GC-Lect Agar; Cat. No. 297715 The device is a selective medium providing enhanced growth and recovery of Neisseria gonorrhoeae and better inhibition of contamination bacteria and fungi. | A portion of this lot was manufactured using Gentamicin instead of Vancomycin. Gentamicin is an inhibitory agent of Neisseria organisms. This product is a selective plated medium to provide enhanced growth and recovery of N gonorrhoeae. Inhibited growth may cause a false negative result or a delayed result leading to incorrect or delayed treatment. | accessdata.fda.gov |
| March 2, 2018 | 79769 | Class III | Terminated | BD MAX DNA MMK (SPC) For Laboratory Use, catalog no. 442829 | The package insert incorrectly lists the volume of the primer and probe diluent to use for the reconstitution of the master mix tube. Adding the incorrect amount of diluent could have an effect on the assay. | accessdata.fda.gov |
| October 3, 2017 | 79217 | Class II | Terminated | Difco" Agar Noble, 500g bottle Noble Agar is a solidifying agent that is essentially free of impurities. It is used in electrophoretic and nutritional procedures and in preparing microbiological culture media when increa | HighPuragar was mislabeled and inadvertently sold as Noble Agar. | accessdata.fda.gov |
| July 18, 2017 | 78808 | Class II | Terminated | BD MAXTM Vaginal Panel. Catalog Number(s): 443712 443710 443711 (RUO)for collection and transport of vaginal and endocervical swab specimens, in addition to the preservation of urine from males and females. | BD recently notified customers in July 2017 regarding an increased rate of unresolved (UNR) and indeterminate (IND) results for the BD MAXTM Vaginal Panel, experienced by some customers. A non-reportable result may lead to repeat of the test and/or re-collection of a specimen. | accessdata.fda.gov |
| June 1, 2017 | 78102 | Class III | Terminated | BD PhoenixTM AP, Catalog Number 448010 The BD Phoenix" AP instrument is designed for use with the BD Phoenix" system is intended to standardize ID broth tube inoculum, add AST indicator to the AST broth tube and transfer | Potential unexpected movement of robot arm | accessdata.fda.gov |
| May 22, 2017 | 77609 | Class II | Terminated | TrypticaseTM Soy Agar with 5% Sheep Blood (TSA IITM), Catalog Number 221261 Trypticase Soy Agar with 5% or 10% Sheep Blood is used for cultivating fastidious microorganisms and for the visualization of hemolytic reaction | Listeria monocytogenes contamination of non-sterile plated media | accessdata.fda.gov |
| May 11, 2017 | 77370 | Class II | Terminated | BD Phoenix PMIC-107, Catalog Number 448417, UDI #s (01)30382904484171, (10)7031818(17)180228(30)0025, IVD. PMIC-107 is a Gram positive AST Only panel used to test antibiotic susceptibility. The inducible macrolide-linosa | BD has recently confirmed quality control failures, related to a manufacturing issue, for the inducible macrolide-linosamide-streptogramin B (iMLSb) test contained on lot 7031818 of Phoenix panels. The iMLSb resistance D-test screen for Staphylococcus species is used to identify phenotypic drug resistance to clindamycin and erythromycin. As the product shoul | accessdata.fda.gov |
| June 1, 2016 | 75375 | Class III | Terminated | PhoenixSpec Calibrator & Kit is used to calibrate the PhoenixSpec & Phoenix AP Instruments. The instruments are then used to measure the turbidity of microbial suspensions equivalent to McFarland standards 0.10 to 4.50. | BD has determined that the BBL PhoenixSpec Calibrator kits referenced in this recall from the following lots (5364776, 5345796 ) are labeled with an incorrect expiration date (year). The expiration date printed on the individual calibration tubes within the kit are correct but difficult to read on a portion of the tubes. | accessdata.fda.gov |
| March 28, 2016 | 73783 | Class II | Terminated | Trypticase TM Soy Agar with 5% Sheep Blood (TSA IITM) // MacConkey II Agar Cat. Number 221291, Lot Number 6034889, Exp. Date : April 20, 2016 Product is sold in cartons of 100 plates each. Product Usage: Trypticase Soy A | Trypticase TM Soy Agar with 5% Sheep Blood (TSA IITM) // MacConkey II Agar is contaminated with Listeria Monocytogenes. The device is a non-sterile prepared plated media. | accessdata.fda.gov |
| February 12, 2016 | 75886 | Class II | Terminated | BD SurePathTM Preservative Collection Vials, catalog numbers 490505, 490527, 491095, 491096, and 491097. SurePath Preservative Fluid is designed for use with the PrepStain System. SurePath Preservative Fluid is an alcoho | BD has confirmed that a portion of BD SurePath" collection vials associated with specific production lots may contain caps that are cracked which can lead to leaking of the preservative fluid. | accessdata.fda.gov |
| December 14, 2015 | 76895 | Class II | Terminated | BD Viper LT software, version 3.00H | BD has confirmed reports that lower than expected RFU values were generated on customer BD Viper LT Systems after the installation of software version 3.00H. As RFU values decrease, results approach the assay cutoff threshold which has the potential to impact test results. | accessdata.fda.gov |
| August 27, 2015 | 76492 | Class II | Terminated | BD AffirM VPIII Microbial Identification Test | BD has confirmed that a portion of tests associated with the affected lots( 446252 and 446257 ) of product may exhibit blue speckles or fibers on the beads and cards, as shown below. This issue would result in an invalid test, as described in the package insert. | accessdata.fda.gov |
| June 29, 2015 | 71883 | Class II | Terminated | Vancomycin Screen Agar | The affected expired lots of product may have exhibited breakthrough growth of vancomycin susceptible Enterococcus facaelis ATCC 29212 near the end of shelf life. The in-date product may also exhibit breakthrough growth of vancomycin susceptible Enterococcus facaelis ATCC 29212 near the end of shelf life. | accessdata.fda.gov |
| March 27, 2015 | 76930 | Class III | Terminated | BBL Trypticase Soy Agar with 5% Sheep Blood (TSA II) and Chocolate II Agar (GC II Agar with Hemoglobin and IsoVitaleX) I Plate Product Usage: Testing - Trypticase Soy Agar with 5% Sheep Blood is used for the growth of fa | BD has confirmed that one lot of TSA II and Chocolate Agar I-Plates may fail to recover Haemophilus influenzae 10211 and Haemophilus parainfluenza 51505 on the Chocolate Agar side of the plate. All other QC organisms are correctly recovered. | accessdata.fda.gov |
| November 21, 2014 | 69954 | Class II | Terminated | BBL Port A Cul tubes, catalog number 221606. Patient sample collection tubes. BBL Port A Cul tubes, jars and vials contain a reduced transport medium and are intended to maintain the viability of anaerobic, facultative a | The products may exhibit indications of excessive oxidation. Excessive oxidation may affect the viability of anaerobic microorganisms. | accessdata.fda.gov |
| November 7, 2014 | 70164 | Class II | Terminated | BD Viper LT System, catalog number 442839 when used in conjunction with the BD ProbeTec Chlamydia trachomatis (CT) Qx Assay (cat. #442959) and the BD ProbeTec Neisseria gonorrhoeae (GC) Qx Assay (cat. #442842). In vitro | Potential for false positive Chlamydia trachomatis (CT) results and Neisseria gonorrhoeae (GC) results when processing the CT Qx and GC Qx Assays on the BD Viper LT Instrument. | accessdata.fda.gov |
| August 25, 2014 | 76498 | Class II | Terminated | EpiCenter Plus Microbiology Data Management System software version 6.20A, when used in conjunction with the MALDI BioTyper System. Product Usage: The EpiCenter system is a clinical data management system designed for us | The information in the EpiCenter interface translation tables was not updated to match the Bruker MALDI BioTyper database identifications for some organisms. This could lead to a possible mis-identification of an organism. | accessdata.fda.gov |
| July 28, 2014 | 69062 | Class II | Terminated | BD BBL Vancomycin Screen Agar Catalog number 222204 Vancomycin Screen Agar is used to test enterococci for resistance to vancomycin and to predict the synergistic activity of this antimicrobial with an aminoglycoside ant | These lots of Agar may have exhibited breakthrough growth of vancomycin susceptible Enterococcus species control organisms. Agar that allows susceptible enterococci to grow appears as a falsely resistant culture. If a lab does not QC, the error would be identified as falsely resistant enterococci would have further AST workup. There could be a delay in the i | accessdata.fda.gov |
| July 23, 2014 | 68991 | Class II | Terminated | The BD MAX MRSA Assay, catalogue #442953. An automated qualitative in vitro diagnostic test for the direct detection of Methicillin-resistant Staphylococcus aureus (MRSA) DNA from nasal swabs in patie. | The performance of the assay no longer conforms to this statement in the Analytical Specificity section of the Package Insert: One hundred-eleven (111) out of 111 MSSA strains tested at extremely high concentrations (> 106 CFU/swab), produced negative results with the BD MAX MRSA Assay. One of the samples tested with each of the CAP surveys MRS5-A 2014 and M | accessdata.fda.gov |
| June 6, 2014 | 69091 | Class II | Terminated | TrypticaseTM Soy Agar with 5% Sheep Blood (TSA IITM) // MacConkey II Agar Trypticase Soy Agar with 5% Sheep Blood is used for the growth of fastidious organisms and for the visualization of hemolytic reactions. MacConkey | A low level of surface and subsurface contamination of Listeria monocytogenes on 9 lots of non-sterile prepared plated media containing sheep blood, typically visible immediately upon removal from the packaging. The contamination is typically observed as 1-3 CFUs per plate when present. | accessdata.fda.gov |
| May 21, 2014 | 68468 | Class III | Terminated | BBL CrystaLEAD Enteric/Nonfermentor (E/NF) Identification (ID) System, catalog number 245000. in vitro diagnostic for the identification of aerobic gram-negative bacteria that belong to the family Enterobacteriaceae as w | A portion of the BBL Crystal Enteric/Nonfermentor (E/NF) Identification kits from lot numbers 3224281 and 3290379 are labeled with incorrect expiration dates. A portion of these kits contain Crystal Inoculum fluid bottles that will expire prior to the date that was printed on the kit carton. The expiration date printed on the individual Crystal Inoculum flui | accessdata.fda.gov |
| December 9, 2013 | 67245 | Class II | Terminated | BD BACTEC FX- Top Unit instrument, catalog number 441385, and Bottom Unit instrument, catalog 441386, available as a single or a stack configuration; Manufactured by BD Diagnostic Systems, 7 Loveton Circle, Sparks, MD 21 | Improperly functioning component of a diagnostic medical device may cause false negative results in clinical specimens. | accessdata.fda.gov |
| October 11, 2013 | 66933 | Class II | Terminated | BD GeneOhm Cdiff Assay, Part #441401, containing Lysis Kit sample buffer tubes, 200 tests/kit; labeled as ***GeneOhm Sciences Canada, Inc. 2555 boul. du Parc-Technologique Quebec, Qc, Canada, G1P 4S5*** The BD GeneOhm" C | An incorrect reagent was packed with an in vitro diagnostic kit, which may cause an increase in unresolved results or false negative results for Clostridium difficile in patient samples. | accessdata.fda.gov |
| September 9, 2013 | 66325 | Class II | Terminated | BBL (tm) MGIT (tm) Mycobacteria Growth Indicator Tube, part # 245122, packaged in 100 ct cartons and labeled in part Product Usage: The Mycobacteria Growth Indicator Tube supplemented with Bactec MGIT Growth Supplement a | An in-vitro diagnostic reagent may be labeled with an incorrect barcode, which when scanned on associated diagnostic instrument may cause a false negative result. | accessdata.fda.gov |
| July 8, 2013 | 65779 | Class II | Terminated | PrepStain AG. For use in the screening and detection of cervical cancer. | PrepStain system rack setting was incorrectly entered on one PrepStain system during a routine preventive maintenance visit by a BD Field Service Representative. | accessdata.fda.gov |
| June 13, 2013 | 65619 | Class II | Terminated | BD Affirm VPIII Microbial Identification Tests, packaged in kits, 120 test\kit, Catalog # 446257 and 24 test\kit, Catalog # 446252; kits are labeled in part ***Becton, Dickinson and Company, 7 Loveton Circle Sparks, MD 2 | In vitro diagnostic test kit may exhibit invalid internal negative control results. | accessdata.fda.gov |
| June 6, 2013 | 65614 | Class II | Terminated | BD BBL Vancomycin Screen Agar, carton of 10 plates, catalog # 222204, labeled in part ***Becton, Dickinson and Company 7 Loveton Circle Sparks, MD 21152 USA www.bd.com/ds*** Vancomycin Screen Agar is used to test enterco | Microbiological identification media may exhibit reduced levels of Vancomycin. | accessdata.fda.gov |
| May 31, 2013 | 65431 | Class III | Terminated | BD MAX Instrument, catalog #441916 Product Usage: The BD MAX System, used in conjunction with the appropriate extraction kits and reagents is capable of automated amplification and detection of target nucleic acid sequen | Electrical power module installed on some in vitro diagnostic instruments does not meet industry standards as labeled. | accessdata.fda.gov |
| March 11, 2013 | 64883 | Class II | Terminated | BBL(tm) Trypticase (tm) Soy Agar with 5% Sheep Blood. Used for culturing microorganisms. | Microbiological media may be contaminated with bacteria. | accessdata.fda.gov |
| February 8, 2013 | 64444 | Class II | Terminated | BD ProbeTec Neisseria gonorrhoeae (GC) Qx Amplified DNA Assay Reagent Pack, REF 441124, contains 12 each Microwells labeled in part ***BD ProbeTec Neisseria gonorrhoeae (GC) Qx Amplified DNA Assay Reagent Pack REF 441124 | Increased levels of false positives in BD Probe Tech Neisseria gonorrhoeae Q Amplified DNA assay kits. | accessdata.fda.gov |
| December 13, 2012 | 63958 | Class II | Terminated | Becton, Dickinson and Company, BBL Crystal Enteric/Nonfermenter ID Kit, Catalog # 24500, cartons of 20 kits, In-vitro diagnostic reagents for microbiological testing. The BBL Crystal Enteric/Nonfermentor (E/NF) identific | In-vitro diagnostic reagents for microbiological testing may be reversed in well positions in the test kit and when utilized may lead to bacteria misidentification. | accessdata.fda.gov |
| December 11, 2012 | 64310 | Class II | Terminated | BD MAX PCR Cartridges Catalog #437519, box of 24 cartridges labeled in part:***BD MAX PCR Cartridges, GeneOhm Sciences Canada, Inc. 2555 boul du Parc-Technologique, Quebec, Canada G1P 4S5***BD Max Group B Streptococcus ( | Cartridges are not sealing properly during PCR testing and may cause false results, indeterminates and/or invalid runs. | accessdata.fda.gov |
| December 10, 2012 | 64008 | Class II | Terminated | BBL(TM) Fildes Enrichment, catalog number 211866, 10 tubes/pack, labeled in part ***Becton Dickinson and Company, Sparks, MD 21152 USA*** Intended Use: Fildes Enrichment may be used to enrich a variety of media for the c | Enrichment media intended to enhance the cultivation of various microorganisms may fail to support the growth of Haemophilus species. | accessdata.fda.gov |
| November 6, 2012 | 63737 | Class II | Terminated | BD Phoenix PMIC-108 Panels, Catalog number 448418, labeled in part ***Becton, Dickinson and Company 7 Loveton Circle Sparks, USA. The BD Phoenix" Automated Microbiology system is intended for the rapid identification (ID | An antibiotic susceptibility test kit may produce false intermediate or false resistant results with clinically significant bacteria. | accessdata.fda.gov |
| October 22, 2012 | 63723 | Class II | Terminated | BD BBL Taxo XV Factor Strips, Catalog number 231104, in shelf pack vials, fifty strips/vial labeled in part ***Becton, Dickinson and Company, 7 Loveton Circle, Sparks, MD 21152 USA, www.bd.com/ds | In vitro diagnostic test kit was not manufactured according to specifications and may cause false negatives or misidentification of Hemophilus species present in patient specimens. | accessdata.fda.gov |
| September 18, 2012 | 63949 | Class II | Terminated | Becton, Dickinson and Company, BD MAX (tm) (6 channel) Instruments, Catalog number 441916, clinical diagnostic instrument. | Clinical diagnostic instrument may exhibit minor defects, which could lead to erroneous test results. | accessdata.fda.gov |
| May 22, 2012 | 62505 | Class II | Terminated | BD GeneOhm MRSA ACP Assay Catalog #441637, box 48 tests labeled in part***GeneOhm Sciences Canada, Inc., 2555 boul, du Parc-Technologique, Quebec, QC, Canada G1P 4S5*** BD GeneOhm MRSA ACP Assay is a qualitative in vitro | Leakage in Cepheid SmartCycler reaction tubes. | accessdata.fda.gov |
| April 12, 2012 | 61769 | Class II | Terminated | BD Gram Stain Kit, containing 1- 250 mL bottle of Gram Crystal Violet, and additional reagents: Gram Iodine (Stabilized), Gram Decolorizer, Gram Safranin. Gram Stain Kits and Reagents are used to stain microorganisms fro | Potential for increase level of artifacts to appear as large, spherical and easy to distinguish or small & more difficult to distinguish from gram positive cocci. | accessdata.fda.gov |
| April 10, 2012 | 61692 | Not yet classified | Terminated | Becton Dickinson Phoenix System Software, catalog # 448035/448046, component of BD automated microbiology system, and used with BD Gram Positive MIC or MIC/ID panels. Product Usage: Automated Microbiology System for the | BD identified an increase in vancomycin-resistant strains that may exhibit erroneous results on all PMIC or PMIC/ID panels and could lead to ineffective treatment regimen in affected patients. | accessdata.fda.gov |
| February 20, 2012 | 61305 | Not yet classified | Terminated | Fildes Enrichment, BBL brand, catalog #211866, in 5 ml tubes,10 tubes/package, manufactured by BD Diagnostic Systems, 250 Schilling Circle, Cockeysville, MD 21030. Fildes Enrichment may be used to enrich a variety of med | In vitro diagnostic reagent is defective and may fail to enhance the growth of microbiological cultures as intended. | accessdata.fda.gov |
| January 30, 2012 | 61170 | Not yet classified | Terminated | BD BBL (tm) Lowenstein-Jensen Medium Deeps, Catalog #221256, packaged in boxes of ten/600 mL tubes. Product Usage: Lowenstein-Jensen Medium is used for the isolation and cultivation of mycobacteria. The medium tubed as d | Media fails to perform as intended with quality control organism Mycobacterium kansasii. | accessdata.fda.gov |
| January 11, 2012 | 61006 | Not yet classified | Terminated | BBL[TM] Lysine Iron Agar, catalog #211363,500 g bottle 2014-03-31. Lysine Iron Agar was developed for use in the differentiation of enteric organisms based on their ability to decarboxylate or dominate lysine and to form | Lysine Iron Agar may not produce the correct biochemical reactions with Quality Control organisms over the shelf life of the product.. | accessdata.fda.gov |
| May 24, 2011 | 59359 | Not yet classified | Terminated | BD MAX DNA Extraction Kit DNA-1 (Urine/Plasma) Catalog Number 437501. Kit contains 24/2D barcode sample preparation reagent tubes ***For use with the BD MAX System *** to extract DNA from Gram-negative bacteria and virus | Sample results maybe switched between time it was scanned with handheld barcode reader and time it was placed in the sample rack, associating sample results to wrong patient. | accessdata.fda.gov |
| April 20, 2011 | 58906 | Not yet classified | Terminated | BBL" OXACILLIN SCREEN AGAR, catalog #221952, box of 10 plates. Oxacillin Screen Agar (originally named MRSA Screen Agar) was developed for the detection of methicillin-resistant Staphylococcus aureus (MRSA). These strain | Oxacillin Screen Agar may not have been produced according to specification and could result in false antibiotic susceptibility test results in patient specimens. | accessdata.fda.gov |
| March 28, 2011 | 59036 | Not yet classified | Terminated | BD BACTEC(tm) MGI (tm) System Software, Catalog 445922, Lot V5.02A. Product Usage: The BACTEC(tm) MGIT (tm) System Software is used in the MGIT 960 and MGIT 320 instruments for the rapid detection of mycobacteria from cl | Software contained three additional set configurations which caused the system to reinitialized the AST set carrier defaults. | accessdata.fda.gov |
| February 28, 2011 | 58066 | Not yet classified | Terminated | BD Phoenix" Panel NMIC/ID-123, Catalog # 448723, packaged 25 panels/carton, and labeled in part ***Becton, Dickinson and Company 7 Loveton Circle Sparks, MD 21152 USA *** The BD Phoenix Automated Microbiology System is i | In vitro diagnostic test kit is defective and may cause false positive or false negative results. | accessdata.fda.gov |
| September 29, 2010 | 58875 | Not yet classified | Terminated | BD ProbeTec" CT/GC/AC Reagent Pack, catalog #440450, labeled in part ***Becton Dickinson and Company, 7 Loveton Circle, Sparks, MD 21152*** The BD ProbeTec" ET Chlamydia trachomatis and Neisseria gonorrhoeae Amplified DN | In vitro diagnostic reagent packs may be underfilled and contribute to invalid quality control testing or false positive patient results. | accessdata.fda.gov |
| August 31, 2010 | 58480 | Not yet classified | Terminated | BACTEC(tm) MGIT(tm) AST Starter Kit, Catalog 445941. Kit contains 16 each of the 5-Tube and 2-Tube Set Carriers. ***Becton, Dickinson and Company 7 Loveton Circle Sparks, Maryland 21152*** The BACTEC MGIT AST system is a | In vitro diagnostic device components are mislabeled. | accessdata.fda.gov |
| August 13, 2010 | 57023 | Not yet classified | Terminated | GasPak EZ Large Incubation Container, a component of the GasPak EZ Gas Generating Container System, catalog # 260672, labeled in part ***Becton Dickinson and Company Loveton Circle Sparks, MD 21152 USA | In vitro diagnostic reagent containers may be defective and could cause incorrect test results in patient samples. | accessdata.fda.gov |
| August 10, 2010 | 58873 | Not yet classified | Terminated | BACTEC" FX System Software, catalog #441398 and #441750 The BD BACTEC" FX instrument is designed for the rapid detection of bacteria and fungi in clinical specimens. Samples are drawn from patients and injected directly | In vitro diagnostic instrumentation may exhibit random operational errors that could delay effective patient treatment. | accessdata.fda.gov |
| May 19, 2010 | 55867 | Not yet classified | Terminated | Difco Salmonella 0 Group A Antigen, catalog #240731, packaged in 5 mL glass vials, labeled in part ***Becton, Dickinson and Company, Sparks, MD 21152 | In vitro diagnostic reagent to aid in the diagnosis of Salmonellosis may exhibit decreased or no reactivity. If proper controls are run with the lot in question, it would become apparent that the antigen is non reactive and patient specimen results should not be reported. If control testing is not performed a salmonella-infected patient could go undiagnosed, | accessdata.fda.gov |
| May 14, 2010 | 57001 | Not yet classified | Terminated | BD Phoenix" ID/AST Panels, Item # PMIC/ID-107, Catalog number 448607, and labeled in part ***Becton, Dickinson and Company 7 Loveton Circle Sparks, MD 21152 USA | The diagnostic reagent packaging may not be completely sealed, which may cause substrate degradation, and produce incorrect test results, including false positive and false negative results. | accessdata.fda.gov |
| March 5, 2010 | 55813 | Not yet classified | Terminated | BD GeneOhm Cdiff Assay, Catalog 441401, 200 tests/kit, labeled, in part ***BD Diagnostics, 2555 Boul. Du Parc-Technologique, Quebec, Canada G1P4S5*** Intended for use as an aid in diagnosis of CDAD. | In vitro diagnostic test kits do not perform to specifications. | accessdata.fda.gov |
| January 25, 2010 | 54374 | Not yet classified | Terminated | BD Shigella poly Group D Antiserum S. sonnei; types I,II, packaged in 3 mL vials, Catalog #24103, and labeled in part. Becton, Dickinson and Company, 7 Loveton Circle, Sparks, MD 21152 USA. Used to confirm the identifica | In vitro diagnostic test reagent may exhibit decreased reactivity. | accessdata.fda.gov |
| December 9, 2009 | 55697 | Not yet classified | Terminated | Difco (TM) Decarboxylase Base Moeller, packaged in 500 gm bottles, labeled in part ***Becton Dickinson Microbiology Systems, Becton Dickinson, Sparks, MD 21152 | Diagnostic test reagents may not meet quality control specifications. | accessdata.fda.gov |
| November 11, 2009 | 53961 | Not yet classified | Terminated | BD BACTEC(TM) Plus + Aerobic/F Medium, catalog 442192, packed in tubes, 50 tubes/case and labeled in part ***Becton Dickinson and Company, Sparks, MD 21152*** BD BACTEC Media are used in a qualitative procedure for the c | The draw volume on test tubes of blood culture medium is marked with graduations that may be confusing for healthcare practitioners using the tubes for appropriate collection of patient samples for microbiological laboratory testing. | accessdata.fda.gov |
| September 28, 2009 | 54068 | Not yet classified | Terminated | BBL(tm) Lactophenol Cotton Blue Stain Droppers, Catalog number 261188, shelf package of 50 droppers, incorrectly labeled in part ***Methylene Blue Loeffler***Becton Dickinson and Company***Packaged in Mexico*** Lactophen | An in-vitro diagnostic reagent used by clinical laboratories was mislabeled. | accessdata.fda.gov |
| September 18, 2009 | 54152 | Not yet classified | Terminated | BD Probetec" ET CT/GC Endocervical Specimen Collection and Dry Transport System-Pink Cap, Catalog number 440476, packed in shelfpack unit of 100 swabs. | Product was shipped beyond its expiration date. | accessdata.fda.gov |
| August 17, 2009 | 54076 | Not yet classified | Terminated | CLAY ADAMS Dynac III Centrifuge, 120V, Model Number 420104 DYNAC III is a multi-purpose centrifuge, designed for clinical laboratories performing separations in hematology, chemistry, urinalysis, blood banking, microbiol | Medical laboratory centrifuge component may have been assembled incorrectly and cause disabling of the safety feature which prevents customers from opening the centrifuge while it is spinning. | accessdata.fda.gov |
| February 19, 2009 | 53755 | Not yet classified | Terminated | BBL (TM) Brain Heart Infusion, Catalog number 221778, package of 100 tubes, 0.5 mL tubes. Product is labeled in part *** Becton Dickinson and Company, 7 Loveton Circle, Sparks, Maryland 21152 USA*** A general purpose liq | In vitro diagnostic test reagent may contain residual material that inhibits the growth of gram positive/gram negative organisms. | accessdata.fda.gov |
Compare with other makers
- All makers of System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
- All makers of Susceptibility Test Discs, Antimicrobial
- All makers of Dna-Reagents, Neisseria
- All makers of Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus
- All makers of System, Blood Culturing
- All makers of Panels, Test, Susceptibility, Antimicrobial
Updated October 9, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.