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HARDY DIAGNOSTICS

FDA registration: United States Last updated 25 Oct 2026

Devices
1,051
Registries
FDA 510(k)FDA
FDA recalls
202 ongoing

Catalogue1,051

Page 20 of 22

Showing 951-1,000 of 1,051

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

FDA registration
United States(from the FDA device records)
Address
1430 WEST MCCOY LN., Orcutt, CA, 93455
Phone
800-266-2222
FDA FEI number
2022807
DUNS number
039981550