Hardy Diagnostics recalls
Hardy Diagnostics appears in 20 official U.S. recall notices indexed by RecallRadar, most recently on 2026-08-12.
Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.
Recall summary
| Recall notices | 20 |
|---|---|
| Published | 2015-04-22 to 2026-08-12 |
| By agency | FDA Device (20) |
| By classification | Class II (19), Class III (1) |
| By status | terminated (18), ongoing (2) |
| Distribution named in notices | AK, AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, LA, MA, MD, ME, MI, MN, MO, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, SC, TN, TX, US, UT, VA, WA, WI, WV, WY |
Recalls
- HardyDisk AST Cefiderocol 30¿g (FDC30) REF Z9435 HardyDisk AST Cefiderocol 30¿g (FDC30) for in vitro agar diffusion susceptibility testing…
FDA Device · Class II · 2026-08-12 · Hardy Diagnostics
Reason: 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, pot… - HardyCHROM CRE, selective and differential culture medium for antimicrobial susceptibility testing, Product Catalog No. G323
FDA Device · Class II · 2025-07-09 · Hardy Diagnostics
Reason: Identified lots failed incoming quality control testing. Lots exhibited breakthrough growth of Klebsiella pneumoniae. - Quickslide GramPro 1 Automated Gram Stanier is a microscope slide stainer
FDA Device · Class II · 2021-06-16 · Hardy Diagnostics
Reason: Instruments were assembled and serviced using a defective lot of tubing, which is part of the pump mechanism within the unit. - Brain Heart Infusion Agar with 6 ug/ml Vancomycin Cat no: G14 Lot no: 472698 Manufactured: 2020-10-29 Expires: 2020-12-28 Container Type: 1…
FDA Device · Class II · 2021-02-03 · Hardy Diagnostics
Reason: Complaints were received reporting of Staphylococcus aureus (ATCC 29213) breakthrough when the strain should have been inhibited. - Viral Transport Medium, 3ml, Ref: R99, Container type: Tube, Packaged: 20 tubes/box, IVD, CVM Transport Media is provided in plastic centri…
FDA Device · Class II · 2020-12-30 · Hardy Diagnostics
Reason: 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… - Strep B Carrot Broth One-Step, Ref
FDA Device · Class III · 2020-11-18 · Hardy Diagnostics
Reason: 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 - HardyCHROM MRSA,REF
FDA Device · Class II · 2020-06-17 · Hardy Diagnostics
Reason: False Positive results due to the MSSA (methicillin-susceptible) strain Staphylococcus aureus (ATCC 29213) breakthrough when this strain should have been inhibited. - QuickSlide MGS-80, Automated Mutli-Slide Gram Stainer/GramPRO-80
FDA Device · Class II · 2016-07-20 · Hardy Diagnostics
Reason: Discrepant culture and gram stain results, which could potentially lead to misdiagnosis or improper treatment of a patient. - Hardy Diagnostics GBS Detect Cat no
FDA Device · Class II · 2016-05-04 · Hardy Diagnostics
Reason: 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. - FB Broth, 10ml (Fastidious Bacteria Broth) Cat. no: K31 Lot: 15231 A fastidious bacteria broth for the enriched cultivation of Neisseria sp…
FDA Device · Class II · 2015-12-30 · Hardy Diagnostics
Reason: The firm is recalling FB Broth Cat. no. K31, Lot no. 15231 because of potential Burkholderia fungorum contamination. - HardyCHROM MRSA Cat no: G307 Lot no: H15155 Expires: 2015-08-13 Container Type: 15x100mm monoplate Packaged: 10 plates/sleeve Storage: 2-8C…
FDA Device · Class II · 2015-09-02 · Hardy Diagnostics
Reason: 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. - Hardy Diagnostics BEA Agar with Vancomycin container type: 15x100mm monoplate packaged: 10 plates/sleeve Product Usage: BEA (Bile Esculin A…
FDA Device · Class II · 2015-08-05 · Hardy Diagnostics
Reason: 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 Amphoteri… - Hardy Diagnostics BEA Agar with VGA container type: 15x100mm monoplate packaged: 10 places/sleeve Product Usage: BEA (Bile Esculin Azide) A…
FDA Device · Class II · 2015-08-05 · Hardy Diagnostics
Reason: 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 Amphoteri… - Hardy Diagnostics BHI with CIPRO, 1ug/ml container type: 16x100mm tube packaged: 20 tubes/box Product Usage: Brain Heart Infusion Broth wit…
FDA Device · Class II · 2015-08-05 · Hardy Diagnostics
Reason: 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 Amphoteri… - Hardy Diagnostics VRE Broth, 5ml container type: 16x100mm tube packaged: 20 tubes/box fill: 5ml Product Usage: BEA (Bile Esculin Azide) Bro…
FDA Device · Class II · 2015-08-05 · Hardy Diagnostics
Reason: 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 Amphoteri… - Hardy Diagnostics MacConkey Agar with CiPRP, 1ug/ml Container type: 15x100mm monoplate packaged: 10 plates/sleeve Product Usage: MacConkey…
FDA Device · Class II · 2015-08-05 · Hardy Diagnostics
Reason: 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 Amphoteri… - Hardy Diagnostics BEA Broth with Vancomycin container type: 13x100mm tube packaged: 20 tubes/box fill: 2ml Product Usage: BEA (Bile Esculin…
FDA Device · Class II · 2015-08-05 · Hardy Diagnostics
Reason: 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 Amphoteri… - Hardy Diagnostics MDR Acinetobacter container type: 15x100mm monoplate packaged: 10 plates/sleeve Product Usage: MDR Acinetobacter is for t…
FDA Device · Class II · 2015-08-05 · Hardy Diagnostics
Reason: 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 Amphoteri… - HardyCHROM VRE Agar-RSR Cat no: GA333 Lot no: H15055 Expires: 2015-07-04 Container type: 15x100mm monoplate Packaged: 10 plates/sleeve Stor…
FDA Device · Class II · 2015-07-29 · Hardy Diagnostics
Reason: Hardy Diagnostics is recalling HardyCHROM VRE Agar due to lack of 510(k) clearance. - Hardy Diagnostics cat no
FDA Device · Class II · 2015-04-22 · Hardy Diagnostics
Reason: 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.