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Data / Medical devices / United States / Hardy Diagnostics

Hardy Diagnostics: FDA-registered device maker in Orcutt, CA, United States, 85 510(k) clearances

Hardy Diagnostics is registered with the FDA (registration 2022807) in Orcutt, CA, United States. It lists 32 device types. The FDA files 85 510(k) clearances under its listings, the newest dated August 20, 2026. 18 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

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Get makers like this oneWatch Hardy Diagnostics
FDA registration number
2022807
Address
1430 West Mccoy LN., Orcutt, CA, United States, 93455
Owner or operator
HARDY DIAGNOSTICS (2022807)
Roles
Contract manufacturer, Manufacturer, Manufacturer for export, Repackager or relabeler, Specification developer
First device listed
December 9, 1992
Registered through
2026
Brand names listed
A8 for Mycoplasma, AFB Nitrate Reagent A, AFB Nitrate Reagent B, AFB Smear Fix, Acanthamoeba Broth, 5ml, Acetamide Agar Slant, Acetate Differential Slnt, Agar Deep, 1.5% and more

Devices it lists

DeviceProduct codeClassRoleSource
Automated Antimicrobial Susceptibility Test System For Positive Blood Culture SamplesSAN2Contract manufactureraccessdata.fda.gov
Basic FuchsinKKW1Repackager or relabeleraccessdata.fda.gov
Culture Media, Anaerobic TransportJSL1Repackager or relabeleraccessdata.fda.gov
Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton AgarJSO2Manufactureraccessdata.fda.gov
Culture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/BrothJTZ2Manufactureraccessdata.fda.gov
Culture Media, EnrichedKZI1Manufactureraccessdata.fda.gov
Culture Media, For Isolation Of Pathogenic NeisseriaJTY2Manufactureraccessdata.fda.gov
Culture Media, General Nutrient BrothJSC1Manufactureraccessdata.fda.gov
Culture Media, Multiple Biochemical TestJSE1Manufactureraccessdata.fda.gov
Culture Media, Non-Propagating TransportJSM1Manufactureraccessdata.fda.gov
Culture Media, Non-Selective And DifferentialJSH1Manufactureraccessdata.fda.gov
Culture Media, Non-Selective And Non-DifferentialJSG1Manufactureraccessdata.fda.gov
Culture Media, Selective And DifferentialJSI1Manufactureraccessdata.fda.gov
Culture Media, Selective And Non-DifferentialJSJ1Manufactureraccessdata.fda.gov
Culture Media, Selective BrothJSD1Manufactureraccessdata.fda.gov
Culture Media, Single Biochemical TestJSF1Manufactureraccessdata.fda.gov
Device, General Purpose, Microbiology, DiagnosticLIB1Manufactureraccessdata.fda.gov
Device, Parasite ConcentrationLKS1Manufacturer, Repackager or relabeler, Specification developeraccessdata.fda.gov
Discs, Strips And Reagents, Microorganism DifferentiationJTO1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical UseLXG1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Gbs Culture Media, Selective And DifferentialPQZ1Manufacturer, Manufacturer for exportaccessdata.fda.gov
General Purpose ReagentPPM1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Monitor, Microbial GrowthJTA1Contract manufacturer, Manufactureraccessdata.fda.gov
Mounting MediaLEB1Manufactureraccessdata.fda.gov
Plasma, Coagulase, Human, Horse And RabbitJTL1Manufacturer, Repackager or relabeler, Specification developeraccessdata.fda.gov
Quality Control SlidesLJG1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Slides, MicroscopeKEW1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Solution, IsotonicJCE1Manufactureraccessdata.fda.gov
Stains, MicrobiologicJTS1Manufactureraccessdata.fda.gov
Supplement, Culture MediaJSK1Manufactureraccessdata.fda.gov
Susceptibility Test Discs, AntimicrobialJTN2Repackager or relabeleraccessdata.fda.gov
System, Test, Automated, Antimicrobial Susceptibility, Short IncubationLON2Contract manufactureraccessdata.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.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
August 20, 2026K262113HardyDisk AST Tebipenem 10µg (TBP10)JTNSubstantially EquivalentHardy Diagnosticsaccessdata.fda.gov
May 11, 2026K260842HardyDisk AST Gepotidacin 10µg (GEP10)JTNSubstantially EquivalentHardy Diagnosticsaccessdata.fda.gov
November 20, 2025K253105HardyDisk AST Cefiderocol 30µg (FDC30)JTNSubstantially EquivalentHardy Diagnosticsaccessdata.fda.gov
May 15, 2025K250454HardyDisk Aztreonam/Avibactam 30/20µg (AZA50)JTNSubstantially EquivalentHardy Diagnosticsaccessdata.fda.gov
August 2, 2024K233534Viral Transport MediumJSMSubstantially EquivalentHardy Diagnosticsaccessdata.fda.gov
July 6, 2023K231568HardyDisk AST Sulbactam/Durlobactam 10/10µg (SUD20)JTNSubstantially EquivalentHardy Diagnosticsaccessdata.fda.gov
June 1, 2023K230827HardyDisk AST Rezafungin 5µg (RZF5)JTNSubstantially EquivalentHardy Diagnosticsaccessdata.fda.gov
September 19, 2019K192326HardyDisk AST Lefamulin 20µg (LMU20)JTNSubstantially EquivalentHardy Diagnosticsaccessdata.fda.gov
July 31, 2019K191931HardyDisk AST Imipenem/relebactam 10/25µg (IMR10/25)JTNSubstantially EquivalentHardy Diagnosticsaccessdata.fda.gov
April 29, 2019K190553HardyCHROM CREJSOSubstantially EquivalentHardy Diagnosticsaccessdata.fda.gov
January 18, 2019K183298HardyDisk AST Omadacycline 30µg (OMC30)JTNSubstantially EquivalentHardy Diagnosticsaccessdata.fda.gov
September 26, 2018K182357HardyDisk AST Eravacycline 20µg (ERV20)JTNSubstantially EquivalentHardy Diagnosticsaccessdata.fda.gov
July 10, 2018K181700HardyDisk AST Plazomicin 30ug (PLZ30)JTNSubstantially EquivalentHardy Diagnosticsaccessdata.fda.gov
March 22, 2018K173903Granada MediumPQZSubstantially EquivalentHardy Diagnosticsaccessdata.fda.gov
October 3, 2017K172621HardyDisk Meropenem/Vaborbactam 20/10µg (MEV30)JTNSubstantially EquivalentHardy Diagnosticsaccessdata.fda.gov
August 1, 2017K171975HardyDisk AST Delafloxacin 5 µg (DLX5)JTNSubstantially EquivalentHardy Diagnosticsaccessdata.fda.gov
May 22, 2017K170586Strep B Carrot Broth One-StepPQZSubstantially EquivalentHardy Diagnosticsaccessdata.fda.gov
November 15, 2016K160512HardyCHROM ESBLJSOSubstantially EquivalentHardy Diagnosticsaccessdata.fda.gov
November 24, 2015K152846HardyDisk AST Ceftolozane/Tazobactam, (30/10ug)- C/T40JTNSubstantially EquivalentHardy Diagnosticsaccessdata.fda.gov
November 24, 2015K152838HardyDisk AST Ceftazidime/Avibactam, (30/20ug)-CZA50JTNSubstantially EquivalentHardy Diagnosticsaccessdata.fda.gov
May 4, 2011K102922HARDYCHROM MRSAJSOSubstantially EquivalentHardy Diagnosticsaccessdata.fda.gov
December 17, 2010K103538HARDYDISK AST CEFTAROLINE, 30 UG MODEL Z939JTNSubstantially EquivalentHardy Diagnosticsaccessdata.fda.gov
January 29, 2008K080019HARDYDISK AST DORIPENEM 10 UGJTNSubstantially EquivalentHardy Diagnosticsaccessdata.fda.gov
August 23, 2006K062245HARDY DISK AST TIGECYCLINE 15 UG, MODELZ936JTNSubstantially EquivalentHardy Diagnosticsaccessdata.fda.gov
June 4, 2002K021420PARACON II/FECAL CONCENTRATOR IILKSSubstantially EquivalentPara Scientific Co.accessdata.fda.gov
June 13, 2001K011384HARDYDISK NOVOBIOCIN, 30MCG, MODEL Z883JTNSubstantially EquivalentHardy Diagnosticsaccessdata.fda.gov
April 26, 2001K011086HARDYDISK BACITRACIN, 10MCG, MODEL Z927JTNSubstantially EquivalentHardy Diagnosticsaccessdata.fda.gov
January 25, 2001K003690HARDYDISK SULFISOXAZOLEJTNSubstantially EquivalentHardy Diagnosticsaccessdata.fda.gov
January 19, 2001K003554HARDYDISK TRIMETHOPRIM 5MCGJTNSubstantially EquivalentHardy Diagnosticsaccessdata.fda.gov
January 17, 2001K003556HARDYDISK AMOXICILLIN/CLAVULANIC ACID, 20/10MCGJTNSubstantially EquivalentHardy Diagnosticsaccessdata.fda.gov
November 2, 2000K002662HARDYDISK CLINDAMYCIN, 2MCGJTNSubstantially EquivalentHardy Diagnosticsaccessdata.fda.gov
October 26, 2000K002664HARDYDISK LEVOFLOXACIN, 5MCGJTNSubstantially EquivalentHardy Diagnosticsaccessdata.fda.gov
October 26, 2000K002661HARDYDISK CEFOTETAN, 30MCGJTNSubstantially EquivalentHardy Diagnosticsaccessdata.fda.gov
October 25, 2000K002656HARDYDISK CEFUROXIME, 30MCGJTNSubstantially EquivalentHardy Diagnosticsaccessdata.fda.gov
July 27, 2000K001728HARDY DISK CLARITHROMYCIN, 15MCGJTNSubstantially EquivalentHardy Diagnosticsaccessdata.fda.gov
April 13, 2000K000526HARDYDISK, CEPHALOTHIN 30MCGJTNSubstantially EquivalentHardy Diagnosticsaccessdata.fda.gov
April 7, 2000K000525HARDYDISK OFLOXACIN 5MCGJTNSubstantially EquivalentHardy Diagnosticsaccessdata.fda.gov
April 7, 2000K000524HARDYDISK, CEFOTAXIME 30MCGJTNSubstantially EquivalentHardy Diagnosticsaccessdata.fda.gov
April 7, 2000K000509HARDYDISK, VANCOMYCIN 30MCGJTNSubstantially EquivalentHardy Diagnosticsaccessdata.fda.gov
April 7, 2000K000440HARDYDISK CEFTRIAXONE 30MCGJTNSubstantially EquivalentHardy Diagnosticsaccessdata.fda.gov
April 7, 2000K000272HARDYDISK, NITROFURANTOINJTNSubstantially EquivalentHardy Diagnosticsaccessdata.fda.gov
April 7, 2000K000271HARDYDISK, SULFA/TRIMETHJTNSubstantially EquivalentHardy Diagnosticsaccessdata.fda.gov
April 7, 2000K000268HARDYDISK, AMPICILLIN, 10MCGJTNSubstantially EquivalentHardy Diagnosticsaccessdata.fda.gov
April 7, 2000K000261HARDYDISK, PIPERACILLIN/TAZOBACTAM, 110MCGJTNSubstantially EquivalentHardy Diagnosticsaccessdata.fda.gov
March 31, 2000K000305HARDYDISK, CEFOXITIN, 30MCGJTNSubstantially EquivalentHardy Diagnosticsaccessdata.fda.gov
March 29, 2000K000304HARDYDISK, TETRACYCLINE 30MCGJTNSubstantially EquivalentHardy Diagnosticsaccessdata.fda.gov
March 24, 2000K000302HARDY DISK, PENICILLIN, 10 UNITSJTNSubstantially EquivalentHardy Diagnosticsaccessdata.fda.gov
March 21, 2000K000259HARDYDISK, CEFTAZIDIME, 30MCGJTNSubstantially EquivalentHardy Diagnosticsaccessdata.fda.gov
March 21, 2000K000258HARDYDISK, CIPROFLOXACIN, 5MCGJTNSubstantially EquivalentHardy Diagnosticsaccessdata.fda.gov
March 21, 2000K000203HARDYDISK, KANAMYCIN, 30MCGJTNSubstantially EquivalentHardy Diagnosticsaccessdata.fda.gov
March 2, 2000K000181HARDYDISK, CARBENICILLIN, 100MCGJTNSubstantially EquivalentHardy Diagnosticsaccessdata.fda.gov
February 29, 2000K000201HARDYDISK, STREPTOMYCIN 10MCGJTNSubstantially EquivalentHardy Diagnosticsaccessdata.fda.gov
February 29, 2000K000182HARDYDISK TOBRAMYCIN, 10MCGJTNSubstantially EquivalentHardy Diagnosticsaccessdata.fda.gov
February 29, 2000K000130HARDYDISK, NALIDIXIC ACID, 30MCGJTNSubstantially EquivalentHardy Diagnosticsaccessdata.fda.gov
February 28, 2000K000183HARDYDISK, PIPERACILLIN, 100MCGJTNSubstantially EquivalentHardy Diagnosticsaccessdata.fda.gov
February 18, 2000K000128HARDYDISK, CEFAZOLIN, 30MCGJTNSubstantially EquivalentHardy Diagnosticsaccessdata.fda.gov
February 17, 2000K994134HARDYDISK OXACILLIN, 1MCGJTNSubstantially EquivalentHardy Diagnosticsaccessdata.fda.gov
February 16, 2000K994150HARDYDISK NORFLOXACIN, 10MCGJTNSubstantially EquivalentHardy Diagnosticsaccessdata.fda.gov
February 16, 2000K994135HARDYDISK ERYTHROMYCIN, 15MCGJTNSubstantially EquivalentHardy Diagnosticsaccessdata.fda.gov
February 11, 2000K994091HARDYDISK GENTAMICIN, 10MCGJTNSubstantially EquivalentHardy Diagnosticsaccessdata.fda.gov
February 11, 2000K994089HARDYDISK CHLORAMPHENICOL, 30MCGJTNSubstantially EquivalentHardy Diagnosticsaccessdata.fda.gov
February 1, 2000K994046HARDYDISK CEFACLOR 30MCGJTNSubstantially EquivalentHardy Diagnosticsaccessdata.fda.gov
January 18, 2000K994132HARDYDISK IMIPENEM, 10MCGJTNSubstantially EquivalentHardy Diagnosticsaccessdata.fda.gov
January 14, 2000K994067HARDY DISK AMPICILLIN/SULBACTAMJTNSubstantially EquivalentHardy Diagnosticsaccessdata.fda.gov
January 10, 2000K994051HARDYDISK DOXYCYCLINE, 30MCGJTNSubstantially EquivalentHardy Diagnosticsaccessdata.fda.gov
December 27, 1999K993993HARDYDISK AMIKACIN 30MCGJTNSubstantially EquivalentHardy Diagnosticsaccessdata.fda.gov
December 21, 1999K993994HARDYDISK AZITHROMYCIN 15MCGJTNSubstantially EquivalentHardy Diagnosticsaccessdata.fda.gov
January 15, 1997K964560BHI W/VANCOMYCIN AGARJSOSubstantially EquivalentHardy Diagnosticsaccessdata.fda.gov
June 17, 1996K961191COLISCREENJTOSubstantially EquivalentHardy Diagnosticsaccessdata.fda.gov
April 18, 1996K960996M. CAT BUTYRATE DISKJTOSubstantially EquivalentHardy Diagnosticsaccessdata.fda.gov
October 16, 1995K951754CULTURE MEDIA, ANTIMICROBIAL SUSCEPTIBILITY TESTJSOSubstantially EquivalentHardy Diagnosticsaccessdata.fda.gov
February 16, 1995K944847KULTSURE/STARSWAB ANAEROBIC TRANSPORT SYSTEMJSLSubstantially EquivalentStarplex Scientific, Inc.accessdata.fda.gov
December 17, 1993K934330TRANSGROWJTYSubstantially EquivalentHardy Diagnosticsaccessdata.fda.gov
December 15, 1993K931864MARTIN LEWIS WITH LINOCMYCINJTYSubstantially EquivalentHardy Diagnosticsaccessdata.fda.gov
March 31, 1988K880121MOELLERS DECARBOXYLASE, BASEJSHSubstantially EquivalentHardy Mediaaccessdata.fda.gov
March 31, 1988K880120MOELLERS DECARBOXYLASE, LYSINEJSFSubstantially EquivalentHardy Mediaaccessdata.fda.gov
March 31, 1988K880119MOELLERS DECARBOXYLASE, ONITHINEJSFSubstantially EquivalentHardy Mediaaccessdata.fda.gov
March 30, 1988K880118MOELLOERS DECARBOXYLASE, ARGININEJSFSubstantially EquivalentHardy Mediaaccessdata.fda.gov
March 30, 1988K880105MULLER HINTON BROTHJTZSubstantially EquivalentHardy Mediaaccessdata.fda.gov
April 14, 1987K870649MRSA SCREEN AGAR (MUELLER HINTON W/NACL & OXACIL.)JTZSubstantially EquivalentHardy Mediaaccessdata.fda.gov
April 14, 1987K870636HEMOPHILUS ID QUAD PLATEJSHSubstantially EquivalentHardy Mediaaccessdata.fda.gov
March 11, 1985K850553MUELLER HINTON AGAR W/CHOCOLATE, MH W/CHOCJTZSubstantially EquivalentHardy Mediaaccessdata.fda.gov
July 6, 1982K821607MUELLER HINTON W/5% SHEEP'S BLOODJTZSubstantially EquivalentHardy Mediaaccessdata.fda.gov
July 6, 1982K821602THAYER MARTINJTYSubstantially EquivalentHardy Mediaaccessdata.fda.gov
July 2, 1981K811646MUELLER HINTON AGARJTZSubstantially EquivalentHardy Mediaaccessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

InitiatedEventClassStatusProductReasonSource
June 8, 202699226Class IIOngoingHardyDisk AST Cefiderocol 30g (FDC30) REF Z9435 HardyDisk AST Cefiderocol 30g (FDC30) for in vitro agar diffusion susceptibility testing is indicated when there is the need to determine the susceptibility of EnterobacterDue to incorrect cartridges include in affected products that there is the potential for false-susceptible or false-resistant susceptibility results and may lead to selection of an ineffective antimicrobial therapy, potentially resulting in delayed appropriate treatment, prolonged infection, or worsening clinical outcome.accessdata.fda.gov
May 6, 202596843Class IIOngoingHardyCHROM CRE, selective and differential culture medium for antimicrobial susceptibility testing, Product Catalog No. G323Identified lots failed incoming quality control testing. Lots exhibited breakthrough growth of Klebsiella pneumoniae.accessdata.fda.gov
April 16, 202187850Class IITerminatedQuickslide GramPro 1 Automated Gram Stanier is a microscope slide stainer.Instruments were assembled and serviced using a defective lot of tubing, which is part of the pump mechanism within the unit.accessdata.fda.gov
December 21, 202087091Class IITerminatedBrain Heart Infusion Agar with 6 ug/ml Vancomycin Cat no: G14 Lot no: 472698 Manufactured: 2020-10-29 Expires: 2020-12-28 Container Type: 15x100mm plate, 18 mlComplaints were received reporting of Staphylococcus aureus (ATCC 29213) breakthrough when the strain should have been inhibited.accessdata.fda.gov
October 23, 202086853Class IITerminatedViral Transport Medium, 3ml, Ref: R99, Container type: Tube, Packaged: 20 tubes/box, IVD, CVM Transport Media is provided in plastic centrifuge tubes and is used for the collection and transport of clinical specimens forThere is a potential for contamination within Viral Transport Media. Use of contaminated Viral Transport Media for the transport of patient specimen may compromise the detection of COVID-19 by the final device used for testing.accessdata.fda.gov
October 6, 202086586Class IIITerminatedStrep B Carrot Broth One-Step, Ref. Z40, UDI: 00819398026499Streptococcus culture medium contains an incorrect expiration date. The culture medium outer box labeling contains an expiration date of 2021-11-10 instead of the correct expiration date of 2020-11-10accessdata.fda.gov
November 14, 201985412Class IITerminatedHardyCHROM MRSA,REF; G307, LOT: 447694, A selective and differential chromogenic medium for the qualitative direct detection of nasal colonization by methicillin-resistant Staphylococcus aureus (MRSA). Not intended to diFalse Positive results due to the MSSA (methicillin-susceptible) strain Staphylococcus aureus (ATCC 29213) breakthrough when this strain should have been inhibited.accessdata.fda.gov
May 24, 201674356Class IITerminatedQuickSlide MGS-80, Automated Mutli-Slide Gram Stainer/GramPRO-80. Systematically stains, rinses, decolorizes, and counter-stains the provided biological sample and slide.Discrepant culture and gram stain results, which could potentially lead to misdiagnosis or improper treatment of a patient.accessdata.fda.gov
March 21, 201673688Class IITerminatedHardy Diagnostics GBS Detect Cat no. A300. Used for the isolation and detection by enhanced hemolysis of gamma-hemolytic (non-hemolytic) Group B Streptococcus.Performance failure; poor hemolytic reaction of non or weakly hemolytic group B streptococcus (GBS) with the target QC organism, Streptococcus agalactiae (ATCC 13813) due to product deterioration.accessdata.fda.gov
November 18, 201572786Class IITerminatedFB Broth, 10ml (Fastidious Bacteria Broth) Cat. no: K31 Lot: 15231 A fastidious bacteria broth for the enriched cultivation of Neisseria spp., Haemophilus spp., Streptococcus spp., Corynebacterium spp., and other fastidiThe firm is recalling FB Broth Cat. no. K31, Lot no. 15231 because of potential Burkholderia fungorum contamination.accessdata.fda.gov
July 9, 201571804Class IITerminatedHardyCHROM MRSA Cat no: G307 Lot no: H15155 Expires: 2015-08-13 Container Type: 15x100mm monoplate Packaged: 10 plates/sleeve Storage: 2-8C on receipt. Light Sensitive. In vitro diagnostic www.HardyDiagnostics.comHardy Diagnostics is recalling HardyCHROm MRSA due to a report of the potential for breakthrough of the methicillin-sensitive Staphylococcus aureus (MSSA) QC strain, ATCC 29213 on the identified lot.accessdata.fda.gov
June 26, 201571602Class IITerminatedHardy Diagnostics MacConkey Agar with CiPRP, 1ug/ml Container type: 15x100mm monoplate packaged: 10 plates/sleeve Product Usage: MacConkey Agar with Ciprofloxacin is used as a screening medium for the selective isolationHardy Diagnostics is recalling MacConkey Agar with Ciprofloxacin, Brain Heart Infusion Broth with Ciprofloxacin 1 ug, MDR Acinetobacter, BEA with Azide and Vancomycin, BEA Agar with Vancomycin, Gentamicin, and Amphotericin B, BEA Broth with Vancomycin, and VRE Broth due to lack of 510(k) clearance.accessdata.fda.gov
June 24, 201571577Class IITerminatedHardyCHROM VRE Agar-RSR Cat no: GA333 Lot no: H15055 Expires: 2015-07-04 Container type: 15x100mm monoplate Packaged: 10 plates/sleeve Storage 2 to 8 degrees C on receipt Chromogenic medium for stool pathogen screening.Hardy Diagnostics is recalling HardyCHROM VRE Agar due to lack of 510(k) clearance.accessdata.fda.gov
March 4, 201570767Class IITerminatedHardy Diagnostics cat no. G327 HardyCHROM SS Agar (HardyCHROM Salmonella Shigella) Cat no: G327 Container type: 15x100mm monoplate Packaged: 10 plates/sleeve Storage: 2 to 8 degrees C. on receipt in dark A selective chroThe firm is recalling HardyCHROM SS, Cat. no. G327 Lot no. 15037 due to a report of possible lack of color development in Shigella organisms in the referenced lot.accessdata.fda.gov
August 21, 200636309Not yet classifiedTerminatedHardyCHROM 0157, Catalogue Number: G305, Lot Numbers: 06192 & 06235, Packaged: 10 plates per sleeve, Hardy Diagnostics, Santa Maria, CA 93455Performance failure; the product is failing to show pigment development for E. coli 0157.accessdata.fda.gov
June 27, 200636048Not yet classifiedTerminatedBHI Agar with Vancomycin, for in vitro diagnostic use. Catalog # G14, Lot# 06136This recall is being conducted due to the performance failure nearing the end of the product shelf life.accessdata.fda.gov
December 31, 200328120Not yet classifiedTerminatedNitrate Reagent A, Cat No. Z71, Lot 3338 Nitrate Reagent B, Cat No. A72, Lot 3338Mislabeled.accessdata.fda.gov
June 25, 200326681Not yet classifiedTerminatedBlood Agar Plates, 5%, Lot 3155A.Customers complained of bacterial contamination of lot A10-3155A.accessdata.fda.gov

Compare with other makers

Updated August 20, 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.