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HARDY DIAGNOSTICS

Last updated September 17, 2026

Information

Country: US
Address: 1430 WEST MCCOY LN., Orcutt, CA, 93455
Website: —
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Email: —
Phone: —
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: 2022807
DUNS Number: —

Catalogue (356)

Page 1 of 8

Device	Model / Reference	Registries	Class	Status
QwikID	IG06020C03	FDA UDI	Class I	Active
HardyCHROM™	J28	FDA UDI	Class II	Active
HardyDisk™	Z8315	FDA UDI	Class II	Active
HardyFlask™	X21	FDA UDI	Class I	Active
HardyDisk™	Z9161	FDA UDI	Class II	Unknown
HardyDisk™	Z9071	FDA UDI	Class II	Unknown
StrepPRO™	PL033HD	FDA UDI	Class I	Active
HardyDisk™	Z8275	FDA UDI	Class II	Active
HardyDisk™	Z8575	FDA UDI	Class II	Active
Coagulase Cryo™	Z202	FDA UDI	Class I	Active
HardyDisk™	Z7291	FDA UDI	Class I	Active
HardyDisk™	Z7071	FDA UDI	Class I	Active
HardyDisk™	Z9475	FDA UDI	Class II	Active
OxiSticks™	Z193	FDA UDI	Class I	Active
HardyDisk™	Z9361	FDA UDI	Class II	Active
HardyDisk™	Z8811	FDA UDI	Class II	Unknown
ClikSeal™	PC4064200	FDA UDI	Class I	Active
Strep B Carrot Broth™	Z46BX	FDA UDI	Class I	Active
HardyDisk™	Z8835	FDA UDI	Class II	Active
HardyDisk™	Z9435	FDA UDI	Class II	Active
ClikSeal™	PC4090200	FDA UDI	Class I	Active
HardyDisk™	Z7191	FDA UDI	Class I	Active
HardyCHROM	G311	FDA UDI	Class I	Active
AnaeroGRO	AG313	FDA UDI	Class I	Active
HardyDisk™	Z9175	FDA UDI	Class II	Active
HardyDisk™	Z8795	FDA UDI	Class II	Active
HardyDisk™	Z9431	FDA UDI	Class II	Active
HardyDisk™	Z8841	FDA UDI	Class II	Active
HardyDisk™	Z8045	FDA UDI	Class II	Active
HardyDisk™	Z8731	FDA UDI	Class II	Unknown
HardyDisk™	Z8221	FDA UDI	Class II	Active
AnaeroGRO	AG061	FDA UDI	Class I	Active
HardyDisk™	Z8855	FDA UDI	Class II	Active
Carrot Broth™	Z140T	FDA UDI	Class I	Active
HardyDisk™	Z7321	FDA UDI	Class I	Active
HardyDisk™	Z8121	FDA UDI	Class II	Active
HardyDisk™	Z8225	FDA UDI	Class II	Active
HardyDisk™	Z7301	FDA UDI	Class I	Active
HardyDisk™	Z9485	FDA UDI	Class II	Active
HardyDisk™	Z8791	FDA UDI	Class II	Active
HardyDisk™	Z9411	FDA UDI	Class II	Active
HardyDisk™	Z9305	FDA UDI	Class II	Active
HardyDisk™	Z9271	FDA UDI	Class II	Active
HardyDisk™	Z8145	FDA UDI	Class II	Active
HardyDisk™	Z9341	FDA UDI	Class II	Active
HardyDisk™	Z8361	FDA UDI	Class II	Active
HardyCHROM	G313	FDA UDI	Class I	Active
HardyDisk™	Z8911	FDA UDI	Class II	Unknown
HardyDisk™	Z8991	FDA UDI	Class II	Active
HardyDisk™	Z8885	FDA UDI	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.