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HARDY DIAGNOSTICS

Last updated September 17, 2026

Information

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

Catalogue (356)

Page 4 of 8

Device	Model / Reference	Registries	Class	Status
HardyCHROM	GA337	FDA UDI	Class I	Unknown
HardyDisk™	Z8321	FDA UDI	Class II	Active
StrepPRO™	PL037HD	FDA UDI	Class I	Active
AnaeroGRO	AG051	FDA UDI	Class I	Unknown
HardyDisk™	Z7031	FDA UDI	Class I	Active
HardyDisk™	Z8905	FDA UDI	Class II	Active
HardyCHROM™	G307	FDA UDI	Class II	Active
StrepPRO™	PL034HD	FDA UDI	Class I	Active
HardyDisk™	Z8055	FDA UDI	Class II	Unknown
CatScreen™	Z110	FDA UDI	Class I	Active
HardyDisk™	Z8115	FDA UDI	Class II	Active
LanaGram™	Z49	FDA UDI	Class I	Active
HardyFlask™	X22	FDA UDI	Class I	Active
AnaeroGRO	AG23H	FDA UDI	Class I	Active
HardyDisk™	Z8365	FDA UDI	Class II	Active
HardyCHROM™	GA307	FDA UDI	Class II	Active
HardyDisk™	Z9495	FDA UDI	Class II	Active
HardyCHROM	J119	FDA UDI	Class I	Active
HardyFlask™	X23	FDA UDI	Class I	Active
HardyDisk™	Z8915	FDA UDI	Class II	Active
QuickSlide™	HP1	FDA UDI	Class I	Unknown
HardyDisk™	Z9241	FDA UDI	Class II	Active
HardyDisk™	Z9391	FDA UDI	Class II	Active
HardyDisk™	Z9385	FDA UDI	Class II	Unknown
HardyDisk™	Z7021	FDA UDI	Class II	Active
AnaeroGRO	AG20H	FDA UDI	Class I	Active
HardyDisk™	Z8271	FDA UDI	Class II	Active
HardyDisk™	Z8475	FDA UDI	Class II	Active
HardyDisk™	Z8235	FDA UDI	Class II	Active
StrepPRO™	PL030HD	FDA UDI	Class I	Active
HardyDisk™	Z8995	FDA UDI	Class II	Unknown
AnaeroGRO	AG901	FDA UDI	Class I	Unknown
HardyDisk™	Z8845	FDA UDI	Class II	Active
HardyCHROM	G337	FDA UDI	Class I	Active
HardyDisk™	Z9451	FDA UDI	Class II	Active
StrepQuick™	Z122	FDA UDI	Class I	Active
HardyDisk™	Z8035	FDA UDI	Class II	Active
HardyDisk™	Z7011	FDA UDI	Class I	Active
HardyDisk™	Z9381	FDA UDI	Class II	Unknown
HardyFlask™	X15	FDA UDI	Class I	Active
StaphTEX™	ST50	FDA UDI	Class I	Active
HardyDisk™	Z9325	FDA UDI	Class II	Active
HardyFlask™	X14	FDA UDI	Class I	Active
HardyCHROM™	G339	FDA UDI	Class I	Active
AnaeroGRO	AG303	FDA UDI	Class I	Active
ClikSeal™	PC4064200S	FDA UDI	Class I	Active
HardyDisk™	Z9461	FDA UDI	Class II	Active
HardyDisk™	Z8241	FDA UDI	Class II	Active
HardyDisk™	Z7025	FDA UDI	Class II	Active
HardyDisk™	Z7051	FDA UDI	Class I	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.