HARDY DIAGNOSTICS

FDA registration: United States Last updated 25 Oct 2026

Devices: 1,051
Registries: GUDIDFDA
FDA recalls: 202 ongoing

Catalogue1,051

Page 18 of 22

HardyFlask™ X19 Ref X19

Class I FDA UDI Active
HardyDisk™ Z9141 Ref Z9141

Class II FDA UDI
N/A K37 Ref K37

Class I FDA UDI Active
N/A L24 Ref L24

Class I FDA UDI Active
N/A C55 Ref C55

Class I FDA UDI
N/A C61 Ref C61

Class I FDA UDI Active
N/A 4000 Ref 4000

Class I FDA UDI
Na 295255 Ref 295255

Class II FDA UDI
N/A R97 Ref R97

Class I FDA UDI Active
N/A W75 Ref W75

Class I FDA UDI Active
Na 294371 Ref 294371

Class II FDA UDI
N/A J67 Ref J67

Class I FDA UDI Active
N/A G12 Ref G12

Class I FDA UDI Active
N/A A66 Ref A66

Class I FDA UDI Active
N/A Z54 Ref Z54

Class I FDA UDI Active
N/A Q06 Ref Q06

Class I FDA UDI
N/A W58 Ref W58

Class I FDA UDI Active
N/A Y22 Ref Y22

Class I FDA UDI
N/A G01 Ref G01

Class I FDA UDI Active
N/A Y119 Ref Y119

Class I FDA UDI
N/A Y311 Ref Y311

Class I FDA UDI Active
HardyFlask™ X25 Ref X25

Class I FDA UDI Active
SporAmpule® BST100 Ref BST100

Class II FDA UDI Active
Na 294838 Ref 294838

Class II FDA UDI
N/A A134 Ref A134

Class I FDA UDI
N/A G223 Ref G223

Class I FDA UDI Active
N/A Y24 Ref Y24

Class I FDA UDI Active
N/A L80 Ref L80

Class I FDA UDI Active
Na 294470 Ref 294470

Class II FDA UDI
N/A Z173 Ref Z173

Class I FDA UDI Active
AnaeroGRO AG701 Ref AG701

Class I FDA UDI
GlabrataQuick™ Z298 Ref Z298

Class I FDA UDI Active
HardyFlask™ X30 Ref X30

Class I FDA UDI Active
N/A Z18 Ref Z18

Class I FDA UDI Active
N/A 3001 Ref 3001

Class I FDA UDI
Na 294098 Ref 294098

Class II FDA UDI
Na 290526 Ref 290526

Class II FDA UDI
N/A R21 Ref R21

Class I FDA UDI Active
N/A J85 Ref J85

Class I FDA UDI Active
Na 295149 Ref 295149

Class II FDA UDI
N/A G251 Ref G251

Class I FDA UDI Active
N/A J92 Ref J92

Class I FDA UDI
N/A L37 Ref L37

Class I FDA UDI Active
N/A A81 Ref A81

Class I FDA UDI Active
N/A L48 Ref L48

Class I FDA UDI Active
N/A R87 Ref R87

Class I FDA UDI Active
Na 295040 Ref 295040

Class II FDA UDI
N/A Y53 Ref Y53

Class I FDA UDI Active
N/A Q04 Ref Q04

Class I FDA UDI
N/A K147 Ref K147

Class I FDA UDI

Showing 851-900 of 1,051

FDA recalls20

Recalls this firm reported to the FDA. Device pages show the recalls that name the device or the 510(k)/PMA it was cleared under.

Showing the 10 most recent of 20 recalls.

2026
- 8 Jun 2026 Z-2887-2026 Class II Ongoing Due to incorrect cartridges include in affected products that there is the potential for false-susceptible or false-resistant susceptibility results and may lead to selection of an ineffective antimicrobial therapy, potentially resulting in delayed appropriate treatment, prolonged infection, or worsening clinical outcome.
2025
- 6 May 2025 Z-2041-2025 Class II Ongoing Identified lots failed incoming quality control testing. Lots exhibited breakthrough growth of Klebsiella pneumoniae.
2021
- 16 Apr 2021 Z-1835-2021 Class II Terminated Instruments were assembled and serviced using a defective lot of tubing, which is part of the pump mechanism within the unit.
2020
- 21 Dec 2020 Z-0919-2021 Class II Terminated Complaints were received reporting of Staphylococcus aureus (ATCC 29213) breakthrough when the strain should have been inhibited.
- 23 Oct 2020 Z-0655-2021 Class II 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.
- 6 Oct 2020 Z-0441-2021 Class III 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
2019
- 14 Nov 2019 Z-2298-2020 Class II Terminated False Positive results due to the MSSA (methicillin-susceptible) strain Staphylococcus aureus (ATCC 29213) breakthrough when this strain should have been inhibited.
2016
- 24 May 2016 Z-2146-2016 Class II Terminated Discrepant culture and gram stain results, which could potentially lead to misdiagnosis or improper treatment of a patient.
- 21 Mar 2016 Z-1571-2016 Class II 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.
2015
- 18 Nov 2015 Z-0470-2016 Class II Terminated The firm is recalling FB Broth Cat. no. K31, Lot no. 15231 because of potential Burkholderia fungorum contamination.

Show all 20 recalls

2015
- 9 Jul 2015 Z-2463-2015 Class II 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.
- 26 Jun 2015 Z-2273-2015 Class II 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.
- 26 Jun 2015 Z-2274-2015 Class II 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.
- 26 Jun 2015 Z-2275-2015 Class II 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.
- 26 Jun 2015 Z-2276-2015 Class II 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.
- 26 Jun 2015 Z-2277-2015 Class II 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.
- 26 Jun 2015 Z-2278-2015 Class II 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.
- 26 Jun 2015 Z-2279-2015 Class II 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.
- 24 Jun 2015 Z-2192-2015 Class II Terminated Hardy Diagnostics is recalling HardyCHROM VRE Agar due to lack of 510(k) clearance.
- 4 Mar 2015 Z-1444-2015 Class II 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.

Information

FDA registration: United States(from the FDA device records)
Address: 1430 WEST MCCOY LN., Orcutt, CA, 93455
Website: hardydiagnostics.com
Email: [email protected]
Phone: 800-266-2222
FDA FEI number: 2022807
DUNS number: 039981550

Catalogue1,051

HardyFlask™ X19 Ref X19

HardyDisk™ Z9141 Ref Z9141

N/A K37 Ref K37

N/A L24 Ref L24

N/A C55 Ref C55

N/A C61 Ref C61

N/A 4000 Ref 4000

Na 295255 Ref 295255

N/A R97 Ref R97

N/A W75 Ref W75

Na 294371 Ref 294371

N/A J67 Ref J67

N/A G12 Ref G12

N/A A66 Ref A66

N/A Z54 Ref Z54

N/A Q06 Ref Q06

N/A W58 Ref W58

N/A Y22 Ref Y22

N/A G01 Ref G01

N/A Y119 Ref Y119

N/A Y311 Ref Y311

HardyFlask™ X25 Ref X25

SporAmpule® BST100 Ref BST100

Na 294838 Ref 294838

N/A A134 Ref A134

N/A G223 Ref G223

N/A Y24 Ref Y24

N/A L80 Ref L80

Na 294470 Ref 294470

N/A Z173 Ref Z173

AnaeroGRO AG701 Ref AG701

GlabrataQuick™ Z298 Ref Z298

HardyFlask™ X30 Ref X30

N/A Z18 Ref Z18

N/A 3001 Ref 3001

Na 294098 Ref 294098

Na 290526 Ref 290526

N/A R21 Ref R21

N/A J85 Ref J85

Na 295149 Ref 295149

N/A G251 Ref G251

N/A J92 Ref J92

N/A L37 Ref L37

N/A A81 Ref A81

N/A L48 Ref L48

N/A R87 Ref R87

Na 295040 Ref 295040

N/A Y53 Ref Y53

N/A Q04 Ref Q04

N/A K147 Ref K147

FDA recalls20

Information