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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 5 of 8

Device	Model / Reference	Registries	Class	Status
HardyCHROM	G309	FDA UDI	Class I	Active
HardyDisk™	Z9301	FDA UDI	Class II	Active
HardyDisk™	Z9181	FDA UDI	Class II	Active
HardyDisk™	Z8471	FDA UDI	Class II	Active
HardyDisk™	Z9395	FDA UDI	Class II	Active
StrepPRO™	PL039HD	FDA UDI	Class I	Active
Nitrocef Matchbook™	Z108	FDA UDI	Class I	Unknown
StaphTEX™	ST1000	FDA UDI	Class I	Active
HardyDisk™	Z7501	FDA UDI	Class I	Active
AlbiQuick™	Z121	FDA UDI	Class I	Active
OxiStrips™	Z93	FDA UDI	Class I	Active
HardyFlask™	X59	FDA UDI	Class I	Active
AnaeroGRO	AG22H	FDA UDI	Class I	Active
HardyDisk™	Z8545	FDA UDI	Class II	Active
HardyDisk™	Z8025	FDA UDI	Class II	Active
HardyDisk™	Z9401	FDA UDI	Class II	Active
HardyDisk™	Z8371	FDA UDI	Class II	Active
AnaeroGRO	AG25H	FDA UDI	Class I	Active
HardyDisk™	Z9471	FDA UDI	Class II	Active
HardyDisk™	Z8815	FDA UDI	Class II	Active
HardyFlask™	X28	FDA UDI	Class I	Active
HardyDisk™	Z8011	FDA UDI	Class II	Active
HardyDisk™	Z8831	FDA UDI	Class II	Unknown
HardyFlask™	X20	FDA UDI	Class I	Active
HardyDisk AST Gepotidacin 10µg (GEP10)	K260842	FDA 510(k)	Class II	Active
HardyDisk™	Z7121	FDA UDI	Class I	Active
HardyDisk™	Z8345	FDA UDI	Class II	Active
HardyDisk™	Z8611	FDA UDI	Class II	Active
QSlide™	QS0700	FDA UDI	Class I	Active
HardyDisk™	Z9121	FDA UDI	Class II	Active
HardyDisk™	Z9345	FDA UDI	Class II	Active
AnaeroGRO	AG601	FDA UDI	Class I	Unknown
HardyCHROM	G343	FDA UDI	Class I	Active
HardyDisk™	Z9441	FDA UDI	Class II	Active
QuickSlide™	GP3	FDA UDI	Class I	Active
HardyDisk™	Z8411	FDA UDI	Class I	Active
HardyFlask™	X19	FDA UDI	Class I	Active
HardyDisk™	Z9141	FDA UDI	Class II	Unknown
HardyFlask™	X25	FDA UDI	Class I	Active
SporAmpule®	BST100	FDA UDI	Class II	Active
AnaeroGRO	AG701	FDA UDI	Class I	Unknown
GlabrataQuick™	Z298	FDA UDI	Class I	Active
HardyFlask™	X30	FDA UDI	Class I	Active
HardyFlask™	X26	FDA UDI	Class I	Active
AnaeroGRO	AG301	FDA UDI	Class I	Active
TransPRO	TPV50	FDA UDI	Class I	Active
HardyFlask™	X10	FDA UDI	Class I	Active
E. coliPRO™	PL070HD	FDA UDI	Class I	Active
M. Cat Butyrate Disk	K960996	FDA 510(k)	Class I	Active
Hardydisk, Piperacillin/Tazobactam, 110mcg	K000261	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.