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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 3 of 8

Device	Model / Reference	Registries	Class	Status
HardyDisk™	Z8571	FDA UDI	Class II	Unknown
StaphTEX™	ST200	FDA UDI	Class I	Active
HardyDisk™	Z7081	FDA UDI	Class I	Active
SporAmpule®	BST20	FDA UDI	Class II	Active
HardyDisk™	Z9015	FDA UDI	Class II	Active
Q-Slide™	Z302	FDA UDI	Class I	Active
HardyDisk™	Z8311	FDA UDI	Class II	Active
HardyDisk™	Z8601	FDA UDI	Class II	Unknown
HardyDisk™	Z8245	FDA UDI	Class II	Active
HardyFlask™	X40	FDA UDI	Class I	Active
HardyDisk™	Z9371	FDA UDI	Class II	Active
HardyDisk™	Z8441	FDA UDI	Class II	Unknown
HardyDisk™	Z8615	FDA UDI	Class II	Active
HardyFlask™	X11	FDA UDI	Class I	Active
HardyDisk™	Z9011	FDA UDI	Class II	Active
HardyDisk™	Z9321	FDA UDI	Class II	Active
HardyDisk™	Z9145	FDA UDI	Class II	Unknown
StrepPRO™	PL032HD	FDA UDI	Class I	Active
HardyDisk™	Z8881	FDA UDI	Class II	Active
HardyDisk™	Z9481	FDA UDI	Class II	Active
CoaguStaph™	Z003	FDA UDI	Class I	Active
Q-Slide™	Z301	FDA UDI	Class I	Active
HardyDisk™	Z9375	FDA UDI	Class II	Unknown
HardyDisk™	Z9351	FDA UDI	Class II	Active
HardyDisk™	Z8735	FDA UDI	Class II	Active
HardyDisk™	Z8851	FDA UDI	Class II	Active
AnaeroGRO	AG19H	FDA UDI	Class I	Active
HardyDisk™	Z7381	FDA UDI	Class I	Active
HardyFlask™	X57	FDA UDI	Class I	Active
HardyCHROM	J35	FDA UDI	Class II	Active
HardyDisk™	Z8341	FDA UDI	Class II	Active
HardyDisk™	Z9445	FDA UDI	Class II	Active
HardyDisk™	Z8015	FDA UDI	Class II	Active
HardyCHROM™	G323	FDA UDI	Class II	Active
HardyDisk™	Z8331	FDA UDI	Class II	Active
HardyDisk™	Z7015	FDA UDI	Class I	Active
HardyDisk™	Z9355	FDA UDI	Class II	Active
HardyDisk™	Z9335	FDA UDI	Class II	Active
HardyDisk™	Z9491	FDA UDI	Class II	Active
StrepPRO™	PL038HD	FDA UDI	Class I	Active
HardyDisk™	Z9075	FDA UDI	Class II	Active
AnaeroGRO	AG302	FDA UDI	Class I	Active
StrepPRO™	PL040HD	FDA UDI	Class I	Active
StrepPRO™	PL035HD	FDA UDI	Class I	Active
HardyDisk™	Z7041	FDA UDI	Class I	Active
HardyCHROM	G301	FDA UDI	Class I	Active
StrepPRO™	PL031HD	FDA UDI	Class I	Active
CarboFerm™	Z98	FDA UDI	Class I	Active
HardyFlask™	X32	FDA UDI	Class I	Active
HardyDisk™	Z8351	FDA UDI	Class II	Unknown

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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.