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HARDY DIAGNOSTICS

US Last updated 23 Oct 2026

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Devices
6
Registries
GUDIDFDA 510(k)FDA
FDA recalls
202 ongoing

Catalogue6

FDA recalls20

Recalls this firm reported to the FDA. Device pages show the recalls that name the device or the 510(k)/PMA it was cleared under.

Showing the 10 most recent of 20 recalls.

  • 2026

    • 8 Jun 2026 Z-2887-2026 Class II Ongoing Due 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.

  • 2025

    • 6 May 2025 Z-2041-2025 Class II Ongoing Identified lots failed incoming quality control testing. Lots exhibited breakthrough growth of Klebsiella pneumoniae.

  • 2021

    • 16 Apr 2021 Z-1835-2021 Class II Terminated Instruments were assembled and serviced using a defective lot of tubing, which is part of the pump mechanism within the unit.

  • 2020

    • 21 Dec 2020 Z-0919-2021 Class II Terminated Complaints were received reporting of Staphylococcus aureus (ATCC 29213) breakthrough when the strain should have been inhibited.
    • 23 Oct 2020 Z-0655-2021 Class II Terminated There 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.
    • 6 Oct 2020 Z-0441-2021 Class III Terminated Streptococcus 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 2020-11-10

  • 2019

    • 14 Nov 2019 Z-2298-2020 Class II Terminated False Positive results due to the MSSA (methicillin-susceptible) strain Staphylococcus aureus (ATCC 29213) breakthrough when this strain should have been inhibited.

  • 2016

    • 24 May 2016 Z-2146-2016 Class II Terminated Discrepant culture and gram stain results, which could potentially lead to misdiagnosis or improper treatment of a patient.
    • 21 Mar 2016 Z-1571-2016 Class II Terminated 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.

  • 2015

    • 18 Nov 2015 Z-0470-2016 Class II Terminated The firm is recalling FB Broth Cat. no. K31, Lot no. 15231 because of potential Burkholderia fungorum contamination.
Show all 20 recalls

  • 2015

    • 9 Jul 2015 Z-2463-2015 Class II Terminated Hardy 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.
    • 26 Jun 2015 Z-2273-2015 Class II Terminated Hardy 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.
    • 26 Jun 2015 Z-2274-2015 Class II Terminated Hardy 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.
    • 26 Jun 2015 Z-2275-2015 Class II Terminated Hardy 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.
    • 26 Jun 2015 Z-2276-2015 Class II Terminated Hardy 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.
    • 26 Jun 2015 Z-2277-2015 Class II Terminated Hardy 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.
    • 26 Jun 2015 Z-2278-2015 Class II Terminated Hardy 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.
    • 26 Jun 2015 Z-2279-2015 Class II Terminated Hardy 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.
    • 24 Jun 2015 Z-2192-2015 Class II Terminated Hardy Diagnostics is recalling HardyCHROM VRE Agar due to lack of 510(k) clearance.
    • 4 Mar 2015 Z-1444-2015 Class II Terminated The 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.

Information

Country
US
Address
1430 WEST MCCOY LN., Orcutt, CA, 93455
Phone
800-266-2222
FDA FEI number
2022807
DUNS number
039981550