Data / Medical devices / United States / Biomerieux, Inc.
Biomerieux, Inc.: FDA-registered device maker in Durham, NC, United States, 10 510(k) clearances
Biomerieux, Inc. is registered with the FDA (registration 3002769706) in Durham, NC, United States. It lists 3 device types. The FDA files 10 510(k) clearances under its listings, the newest dated May 15, 2019. 48 recall events name it as the recalling firm (1 Class I). Registered through 2027. FDA data exported November 3, 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
- 3002769706
- Address
- 100 Rodolphe ST, Durham, NC, United States, 27712
- Owner or operator
- BIOMERIEUX SA (8020790)
- Roles
- Manufacturer, Specification developer
- First device listed
- December 27, 2007
- Registered through
- 2027
- Brand names listed
- BACT/ALERT BPA Culture Bottle, BACT/ALERT BPN Culture Bottle, BACT/ALERT FA PLUS CULTURE BOTTLE, BACT/ALERT FN PLUS, BACT/ALERT MP Reagent System, BACT/ALERT PF PLUS CULTURE BOTTLE, BIOMERIEUX WORKSAFE Blood Culture Collection Kit : Charcoal, BIOMERIEUX WORKSAFE Blood Culture Collection Kit : Charcoal Combo and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Blood And Urine Collection Kit (Excludes Hiv Testing) | OIB | 1 | Specification developer | accessdata.fda.gov |
| System, Blood Culturing | MDB | 1 | Manufacturer | accessdata.fda.gov |
| System, Detection, Bacterial, For Platelet Transfusion Products | MZC | 1 | Manufacturer | accessdata.fda.gov |
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.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| May 15, 2019 | K190405 | BACT/ALERT MP Reagent System | MDB | Substantially Equivalent | bioMerieux, Inc. | accessdata.fda.gov |
| February 11, 2019 | K183166 | BacT/ALERT FA Plus; BacT/ALERT PF Plus | MDB | Substantially Equivalent | bioMerieux, Inc. | accessdata.fda.gov |
| January 25, 2013 | K121455 | BACT/ALERT FN PLUS CULTURE BOTTLE | MDB | Substantially Equivalent | bioMerieux, Inc. | accessdata.fda.gov |
| January 25, 2013 | K121446 | BACT/ALERT PF PLUS CULTURE BOTTLE | MDB | Substantially Equivalent | bioMerieux, Inc. | accessdata.fda.gov |
| January 22, 2013 | K121461 | BACT/ALERT FA PLUS CULTURE BOTTLE | MDB | Substantially Equivalent | bioMerieux, Inc. | accessdata.fda.gov |
| April 26, 2002 | K021123 | BACT/ALERT SN CULTURE BOTTLE | MDB | Substantially Equivalent | bioMerieux, Inc. | accessdata.fda.gov |
| April 18, 2002 | K020931 | BACT/ALERT SA CULTURE BOTTLE | MDB | Substantially Equivalent | bioMerieux, Inc. | accessdata.fda.gov |
| April 18, 2002 | K020923 | BACT/ALERT PF CULTURE BOTTLE | MDB | Substantially Equivalent | bioMerieux, Inc. | accessdata.fda.gov |
| April 18, 2002 | K020815 | BACT/ALERT FN CULTURE BOTTLE | MDB | Substantially Equivalent | bioMerieux, Inc. | accessdata.fda.gov |
| April 17, 2002 | K020813 | BACT/ALERT FA CULTURE BOTTLE | MDB | Substantially Equivalent | bioMerieux, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| June 26, 2025 | 97269 | Class II | Ongoing | VITEK 2 Gram-negative AST Test Kits (Cards) containing Colistin formulation cs02n. VITEK 2 is an automated system consisting of instruments, software and reagent cards designed for the identification and antimicrobial su | Potential for false resistant results for Colistin (cs02n) with multi-drug-resistant Pseudomonas aeruginosa and Acinetobacter baumannii complex used in specific cards | accessdata.fda.gov |
| July 20, 2022 | 90596 | Class II | Ongoing | NUCLISENS easyMAG Magnetic Silica, REF 280133, 24 x 1.2mL bottles/kit. | There is a potential of no result leading to possible delayed result due to contamination of extraction reagents. | accessdata.fda.gov |
| July 13, 2022 | 90605 | Class II | Ongoing | VITEK 2 / MYLA VITEK 2 Software versions 8.01, 8.02 (veterinary use only), 9.01, 9.02, 9.03 MYLA Software versions V4.8 and V4.9 | There are 7 reported software anomalies that may affect use of the device. | accessdata.fda.gov |
| March 29, 2022 | 89929 | Class II | Ongoing | VITEK 2 Systems and VITEK 2 with MYLA. | Software issue where results sent to the LIS via HL7 format for antibiotic screen tests and synergy tests do not include the user-corrected or AES-corrected interpretation. This can potentially lead to incorrect final screen/synergy test results at the LIS. | accessdata.fda.gov |
| February 9, 2022 | 89568 | Class II | Terminated | VIDAS CMV IgM, 30 tests, REF 30205-01, IVD, Rx. | Invalid calibrations (out of range high) while using the product. | accessdata.fda.gov |
| September 30, 2021 | 88844 | Class II | Terminated | API 50 CH, Model 50300 | There is potential to provide an incorrect organism identification. | accessdata.fda.gov |
| September 22, 2021 | 88797 | Class II | Ongoing | VIDAS PRG Progesterone, REF 30409-01 | bioMerieux has been receiving an increasing number of complaints linked to a VIDAS substrate error. It prevents the test from being run, therefore leads to potential delayed results as the user must run another test. | accessdata.fda.gov |
| February 5, 2020 | 84993 | Class II | Terminated | VITEK 2 card AST-N371 - Product Usage: The VITEK 2 is an automated system consisting of instruments, software, and reagent cards designed for the identification and antimicrobial susceptibility testing of bacteria and ye | The top seal of some of the pouches was compromised which can allow moisture to enter that can impact some antibiotics on the card. | accessdata.fda.gov |
| January 24, 2020 | 84737 | Class II | Terminated | PREVI Isola Insrument and PREVI Isola Printer spares PSUs (power supply units), P1028888-001 PSU (used in Zebra LP2824 Plus printers) PSUs with the following date code; 0639XX through 1253XX (YYWWXX, where YY=Year, and W | The recall has been initiated due to potential for overheating or a fire hazard associated with the Zebra LP2824 Plus printer PSU (power supply unit) located within the PREVI Isola instrument. | accessdata.fda.gov |
| December 10, 2019 | 84439 | Class II | Terminated | VIDAS Varicella Zoster IgG (VZG) antibody IVD, kit | Two batches of VIDAS Varicella-Zoster IgG (VZG ref 30217) may yield an invalid calibration which may delay the patient's sample result or a valid calibration may lead to a false positive patient result. | accessdata.fda.gov |
| March 15, 2019 | 82501 | Class II | Terminated | Biomerieux Vitek 2 Test kit VITEK 2 is an automated system consisting of instruments, software and reagent cards designed for the identification and antimicrobial susceptibility testing of bacteria and yeast. | Unexpected ESBL (Extended Spectrum Beta Lactamase) phenotype had been proposed for some Escherichia coli strains in conjunction with the VITEK 2 AST-N254, AST-N330, AST-N371 (ref.413723,418674, 422024) test kits. | accessdata.fda.gov |
| December 13, 2018 | 81953 | Class II | Terminated | VITEK 2 AST-N351 Test Kit | False Positive ESBL Phenotype | accessdata.fda.gov |
| November 13, 2018 | 81589 | Class II | Terminated | VITEK 2 Systems Software Version 9.01 Update Kit. | The VITEK 2 Systems Software Version 9.01 software may display incorrect organism identification information as well as the associated Antimicrobial Susceptibility Testing (AST) results when using the VITEK 2 FLEXPREP" feature. | accessdata.fda.gov |
| October 22, 2018 | 81415 | Class II | Terminated | VITEK 2 Antimicrobial Susceptibility Testing (AST) using one or more of these susceptibility products: Catalog # 410028, VITEK 2 AST-ST01 Catalog # 420915, VITEK 2 AST-ST02 Catalog # 421040, VITEK 2 AST-ST03 The VITEK 2 | False resistant results for Streptococcus anginosus and Streptococcus constellatus strains were reported. | accessdata.fda.gov |
| October 8, 2018 | 81323 | Class II | Terminated | bioMrieux NucliSENS easyMAG Lysis Buffer ref. 280134 | Some eluates become colored because of remaining hemoglobin in the eluate. | accessdata.fda.gov |
| August 13, 2018 | 80860 | Class II | Terminated | VITEK(R) 2 AST-P640, For susceptibility testing of Staphylococcus spp. Enterococcus spp., ad S agalactiae against specified antimicrobials, REF 418579 Product Usage: VITEK 2 is an automated system consisting of instrumen | Routine internal review of Device History Records identified six VITEK(R) 2 AST card lots were manufactured with less drug (gentamicin) than required for the Gentamicin High-Level Resistance (ghlr01n) screen test due to an error when making 1500mL and 2000mL media well preparations (solutions). | accessdata.fda.gov |
| June 27, 2018 | 80759 | Class II | Terminated | BACT/ALERT VIRTUO system, A Unit, with Version R2.0 Firmware Product Usage: The BacT/ALERT VIRTU Microbial Detection System is an automated microbial test system capable of incubating, agitating, and continuously monitor | The BACT/ALERT VIRTUO Instrument Firmware version R2.0 allows relocation of the four (4) resident calibration standards so that Field System Engineers (FSE) can service the associated cells P24 - P27, where the calibration standards typically reside. If the calibration standards are not returned to the designated locations, an anomaly may occur. | accessdata.fda.gov |
| March 1, 2018 | 80087 | Class II | Terminated | VIDAS LH, Reference Numbers 30406 and 30406-01. Poduct Usage: VIDAS LH is an automated quantitative test for use on the VIDAS family instruments for the determination of human luteinizing hormone in human serum or plasma | Several complaints were received for invalid calibration with low calibrator S1 while using VIDAS LH. Internal tests confirmed a decrease of the strips signal overtime for specific lots. | accessdata.fda.gov |
| January 26, 2018 | 80619 | Class I | Terminated | bioMerieux VITEK 2 Gram Positive Cefoxitin Screen, VITEK 2 Gram Positive AST for Oxacillin, VITEK SYSTEMS General Susceptibility Card Cefotoxin and AST for Oxacillin bioMerieux VITEK 2 AST-P631 bioMerieux VITEK 2 AST-GP6 | Customer reports indicated an increase in the rate of non-detected MRSA in association with the VITEK 2 AST-P631 product. | accessdata.fda.gov |
| January 4, 2018 | 79993 | Class II | Terminated | BioMerieux mini VIDAS System in combination with Quality Control VIDAS* (QCV*) Product Usage: the Quality Control VIDAS (QCV) is an automated test for use on the VIDAS system to detect abnormal operation of the VIDAS and | Increase of events affecting performance regarding pump clogging and displacement of the color-coded SPR label (DOT). These performance issues could contribute to erroneous results for any assay performed on the VIDAS and mini VIDAS system due to a decrease of pipetted volume. | accessdata.fda.gov |
| May 15, 2017 | 77292 | Class II | Terminated | VIDAS Testosterone, Ref 30418 | Complaints were received from customers observing falsely overestimate results or external quality control higher results than expected when performing tests with VIDAS Testosterone. | accessdata.fda.gov |
| April 10, 2017 | 77989 | Class II | Terminated | eMAG System, Ref 418591 It is an In Vitro Diagnostic Medical device intended for the automated isolation (purification and concentration) of total nucleic acids (RNA/DNA) from biological specimens, with liquid and homoge | Some anomalies have been identified during manufacturing controls. | accessdata.fda.gov |
| December 24, 2015 | 73027 | Class II | Terminated | BacT/ALERT SN, bioMrieux, Inc. Product Usage: BacT/ALERT Culture Bottles are used with the BacT/ALERT Microbial Detection System in qualitative procedures for enhanced recovery and detection of aerobic and facultative an | Bottles may have been exposed to non-normal shipping conditions which may lead to media degradation and impact growth performance. | accessdata.fda.gov |
| November 3, 2015 | 72643 | Class II | Terminated | MYLA CLINIC PATCH 3.2.0 CD Product Usage: MYLA is a computer application (Middleware) based on Web 2.0 technology which: Interfaces between the instruments connected to the application and the LIS(s) (Laboratory Informat | MYLA software connected to a Laboratory Information System (LIS) and a VITEK 2 system has the potential to link a test result to an incorrect patient record with the same specimen ID. | accessdata.fda.gov |
| April 14, 2015 | 71049 | Class II | Terminated | MYLA server HP Proliant: DL380-G8 and ML350-G6 version 3.xx computer application software. MYLA V3 is a computer application ("Middleware") based on Web 2.0 technology which: Interfaces between the instruments connected | The MYLA server could slow down due to the volume (weight) of the data to manage and it could also stop processing, impacting the server start-up phase. The problem occurs in high volume settings. The MYLA server slows down and will stop processing completely if any task requires more than 5 minutes to complete. The server then fails to reboot and requires s | accessdata.fda.gov |
| September 6, 2013 | 66290 | Class II | Terminated | chromID Salmonella Agar, Reference No. 43621. A selective isolation and differentiation medium for the detection of Salmonella in human specimens. | Complaints for Salmonella strains growing on this medium producing an uncharacteristic white colored colony instead of the expected pale pink to mauve colored colonies. This could potentially lead to Salmonella colonies not being detected. | accessdata.fda.gov |
| December 25, 2012 | 64054 | Class II | Terminated | BacT/ALERT SA Blood Culture Bottle. The BacT/ALERT SA reagent bottle is intended to be recover and detect aerobic microorganisms (bacteria and fungi) from blood and other normally sterile body fluids. | BacT/ALERT SA Culture Bottle lot 1031866 may contain bottles with uncured sensors. | accessdata.fda.gov |
| March 5, 2012 | 61362 | Not yet classified | Terminated | BacT/ALERT Blood Collection Adapter The BacT/ALERT Adapter Cap is intended for use as an aid to facilitate filling of blood into the BacT/alert Blood Culture Bottle when using a butterfly blood collection set. | The BacT/ALERT Blood Collection Adapter Cap is no longer compatible with Becton Dickinson (BK) Vacutainer Safety Lok Blood Collection Set. The incompatibility is the blood collection set needle backing out of the adapter cap that results in an exposed sheathed needle that may lead to an accidental needlestick. | accessdata.fda.gov |
| December 21, 2011 | 60990 | Not yet classified | Terminated | SLIDEX Staph kit (250 Tests). The SLIDEX Staph-Kit is a rapid latex and red blood cell agglutination test for the identification of Staphylococcus aureus strains from culture media. | Reports of false negative results in organism identification. | accessdata.fda.gov |
| July 8, 2011 | 59601 | Not yet classified | Terminated | VIDAS Chlamydia test kits VIDAS Chlamydia is an automated qualitative test for use on the VIDAS family instruments, for the detection of Chlamydia antigen in endocervical or urethral specimens, using the ELFA technique ( | Complaints were received of high rates of false positive results, leading to unnecessary antibiotic therapy being prescribed to patients. | accessdata.fda.gov |
| May 10, 2011 | 58792 | Not yet classified | Terminated | NucliSens EasyQ Enterovirus serotype 68 v1.1: Catalog number: 200300 In Vitro Diagnostic Test | The NucliSENS EasyQ Enterovirus Reagents are unable to detect Enterovirus serotype 68, in respiratory samples. | accessdata.fda.gov |
| April 13, 2011 | 58550 | Not yet classified | Terminated | BacT/ALERT - FA Reagent Bottle The BacT/ALERT Microbial Detection System is used to determine if microorganisms are present in blood or other normally sterile body fluid samples taken from a patient suspected of having b | The charcoal suspension in a portion of the lot does not meet the intended density. | accessdata.fda.gov |
| November 5, 2007 | 45799 | Not yet classified | Terminated | bioMerieux, BacT/ALERT FA Culture Bottles, bioMerieux, Inc., Durham, NC 27704 | Duplicate Bottle Indentification -- Three lot numbers of BacT/ALERT FA Culture Bottles labels contained duplicate bottle identification (Bottle ID) barcode numbers. (Lots 1017685 and 1017788 contain the same series of Bottle ID's; Lot 1017693 contains duplicate Bottle ID's within the lot and may share Bottle ID's with both lots 1017685 and 1017788) | accessdata.fda.gov |
| February 16, 2007 | 38433 | Not yet classified | Terminated | BacT/ALERT FN Culture Bottles, Product Number 259793 | Microbial Contamination: Bacillus sp. contamination was detected in inoculated bottles. | accessdata.fda.gov |
| January 11, 2007 | 37133 | Not yet classified | Terminated | BacT/ALERT FA Culture Bottles, 30 ml, for in vitro diagnostic use, BioMerieux, Inc., Durham, NC 27704 | Bacillus sp. contamination was detected in inoculated and uninoculated bottles of BacT/ALERT FA Culture bottles. | accessdata.fda.gov |
| December 19, 2006 | 37141 | Not yet classified | Terminated | BacT/VIEW C.30a Software update (P/N 514515-1) diagnostic data management system, bioMerieux, Inc., P. O. Box 15969, Durham, NC 27704-0969 USA | Bottle data is not sent to BacT/ALERT 3D instrument. | accessdata.fda.gov |
| December 19, 2006 | 37136 | Not yet classified | Terminated | BacT/VIEW Software, all versions. in vitro diagnostic database software. | BacT/VIEW will be unable to run scheduled macro applications unless the user touches the BacT/VIEW touch screen or clicks a function after resynchronizing the clocks. | accessdata.fda.gov |
| August 17, 2006 | 36239 | Not yet classified | Terminated | bioMerieux BacT/ALERT SN Anaerobic Culture Bottle-REF 259790 | Recovery Compromised-during manufacturing ambient air (including oxygen) was inadvertently introduced into the culture bottles, changing their reduction/oxidation potential thus leading to a compromised recovery of some obligate anaerobes and longer detection times. | accessdata.fda.gov |
| August 14, 2006 | 36826 | Not yet classified | Terminated | BacT/ALERT Classic System Software, Blood Culturing System | Plastic bottle samples assigned less sensitive default glass bottle algorithm instead of the plastic bottle algorithm on BacT/ALERT Microbial Detection Systems. | accessdata.fda.gov |
| August 19, 2005 | 33440 | Not yet classified | Terminated | VeriCal Calibrator Set | The product is being recalled due to mis-assignment of ISI values associated with VeriCal use. | accessdata.fda.gov |
| May 27, 2005 | 32377 | Not yet classified | Terminated | Bac T/ALERT 3D Control Module | A Bac T/ALERT 3D system failed to detect a positive sample in a pediatric BAC T/ALERT PF bottle. | accessdata.fda.gov |
| March 7, 2005 | 31482 | Not yet classified | Terminated | Simplastin HTF Reagents, 20ml HO, ( and 6 ml HO) bioMerieux, Inc., Durham, NC 27704 | The ISI labeling for Simplastin HTF on the Coag-a-Mate MAX and Thrombolyzer instrument platforms is not correct. The Simplastin HTF ISI assignment was mis-assigned and the published values are higher than expected for the listed instrument platforms. | accessdata.fda.gov |
| September 17, 2004 | 30261 | Not yet classified | Terminated | BacT/ALERT(BTA) Classic instruments. | Over heating of memory board. | accessdata.fda.gov |
| August 20, 2004 | 30013 | Not yet classified | Terminated | MDA Fibriquik, bioMeriux, Inc., Box 15969, Durham, North Carolina 27704-0969 | Complaints were received from the field regarding prolonged clot times, high control values and erratic results. | accessdata.fda.gov |
| June 11, 2004 | 30026 | Not yet classified | Terminated | The MDA system with MDA Antithrombin III MDA Heparin | The firm received complaints regarding an observed bias in percent activity between capped and uncapped specimens. | accessdata.fda.gov |
| June 9, 2004 | 29330 | Not yet classified | Terminated | VIDAS CMV IgG Assay | The product may give false positive results. | accessdata.fda.gov |
| August 6, 2003 | 26945 | Not yet classified | Terminated | VIDAS Chlamydia Assay (CHL) for In-Vitro Diagnostic Use Product Number: 30101 | Product's decrease in sensitivity may result in false negative results | accessdata.fda.gov |
| July 31, 2003 | 27008 | Not yet classified | Terminated | Simplastin L, Prothrombin Time test, 10 vials (20 ml each), Product Number 259553, bioMerieux | Complaints of prolonged clot times. | accessdata.fda.gov |
Compare with other makers
- All makers of System, Detection, Bacterial, For Platelet Transfusion Products
- All makers of System, Blood Culturing
- All makers of Blood And Urine Collection Kit (Excludes Hiv Testing)
Updated September 29, 2025. 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.