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Hardy Diagnostics

Hardy Diagnostics Recalls

All product recalls associated with Hardy Diagnostics.

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Recall Summary

Total Recalls

6

Past Year

1

Class I (Serious)

0

Most Recent

May 2025

Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.

Showing 1–6 of 6 recalls

HardyCHROM CRE (Hardy Diagnostics) – Quality Control Failure (2025)

Identified lots failed incoming quality control testing. Lots exhibited breakthrough growth of Klebsiella pneumoniae.

FDAMay 6, 2025AZ, CA, CO +19 more• Hardy Diagnostics

Hardy Diagnostics: Quickslide GramPro 1 Automated Gram Stanier is a microsco...

Instruments were assembled and serviced using a defective lot of tubing, which is part of the pump mechanism within the unit.

FDAApr 16, 2021Nationwide• Hardy Diagnostics

Hardy Diagnostics: Brain Heart Infusion Agar with 6 ug/ml Vancomycin Cat no:...

Complaints were received reporting of Staphylococcus aureus (ATCC 29213) breakthrough when the strain should have been inhibited.

FDADec 21, 2020AZ, CA, CT +8 more• Hardy Diagnostics

Hardy Diagnostics: Viral Transport Medium, 3ml, Ref: R99, Container type: Tu...

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.

FDAOct 23, 2020Nationwide• Hardy Diagnostics

Hardy Diagnostics: Strep B Carrot Broth One-Step, Ref. Z40, UDI: 0081939802...

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

FDAOct 6, 2020AL, AK, AZ +18 more• Hardy Diagnostics

Hardy Diagnostics: HardyCHROM MRSA,REF; G307, LOT: 447694, A selective and d...

False Positive results due to the MSSA (methicillin-susceptible) strain Staphylococcus aureus (ATCC 29213) breakthrough when this strain should have been inhibited.

FDANov 14, 2019AZ, CA, IN +11 more• Hardy Diagnostics