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HARDY DIAGNOSTICS

Last updated September 17, 2026

Information

Country: US
Address: 1430 WEST MCCOY LN., Orcutt, CA, 93455
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FDA FEI Number: 2022807
DUNS Number: —

Catalogue (356)

Page 8 of 8

Device	Model / Reference	Registries	Class	Status
Hardydisk Oxacillin, 1mcg	K994134	FDA 510(k)	Class II	Active
Hardydisk Amoxicillin/Clavulanic Acid, 20/10mcg	K003556	FDA 510(k)	Class II	Active
Bhi W/Vancomycin Agar	K964560	FDA 510(k)	Class II	Active
HardyDisk AST Gepotidacin 10µg (GEP10)	K250956	FDA 510(k)	Class II	Active
Hardydisk, Nalidixic Acid, 30mcg	K000130	FDA 510(k)	Class II	Active
Hardydisk Ceftriaxone 30mcg	K000440	FDA 510(k)	Class II	Active

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FDA Recalls (19)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
May 6, 2025	Z-2041-2025	—	open, classified	Identified lots failed incoming quality control testing. Lots exhibited breakthrough growth of Klebsiella pneumoniae.
Apr 16, 2021	Z-1835-2021	—	terminated	Instruments were assembled and serviced using a defective lot of tubing, which is part of the pump mechanism within the unit.
Dec 21, 2020	Z-0919-2021	—	terminated	Complaints were received reporting of Staphylococcus aureus (ATCC 29213) breakthrough when the strain should have been inhibited.
Oct 23, 2020	Z-0655-2021	—	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.
Oct 6, 2020	Z-0441-2021	—	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
Nov 14, 2019	Z-2298-2020	—	terminated	False Positive results due to the MSSA (methicillin-susceptible) strain Staphylococcus aureus (ATCC 29213) breakthrough when this strain should have been inhibited.
May 24, 2016	Z-2146-2016	—	terminated	Discrepant culture and gram stain results, which could potentially lead to misdiagnosis or improper treatment of a patient.
Mar 21, 2016	Z-1571-2016	—	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.
Nov 18, 2015	Z-0470-2016	—	terminated	The firm is recalling FB Broth Cat. no. K31, Lot no. 15231 because of potential Burkholderia fungorum contamination.
Jul 9, 2015	Z-2463-2015	—	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.
Jun 26, 2015	Z-2277-2015	—	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.
Jun 26, 2015	Z-2276-2015	—	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.
Jun 26, 2015	Z-2274-2015	—	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.
Jun 26, 2015	Z-2279-2015	—	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.
Jun 26, 2015	Z-2273-2015	—	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.
Jun 26, 2015	Z-2278-2015	—	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.
Jun 26, 2015	Z-2275-2015	—	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.
Jun 24, 2015	Z-2192-2015	—	terminated	Hardy Diagnostics is recalling HardyCHROM VRE Agar due to lack of 510(k) clearance.
Mar 4, 2015	Z-1444-2015	—	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.