Hardy Diagnostics recalls specific lots of HardyCHROM CRE culture media due to Klebsiella pneumoniae growth in some batches. Affected lots were manufactured in March and April 2025 and expire by May 2025. Consumers should check product labels for lot numbers.
Identified lots failed incoming quality control testing. Lots exhibited breakthrough growth of Klebsiella pneumoniae.
Hardy Diagnostics is recalling specific lots of HardyCHROM CRE culture media because some batches showed unexpected growth of Klebsiella pneumoniae bacteria during quality checks. This could lead to inaccurate antibiotic testing results if used in medical labs.
The recalled lots failed quality control tests and showed Klebsiella pneumoniae bacteria growing through the culture medium. This could cause false antibiotic susceptibility results in lab tests, potentially affecting treatment decisions.
Laboratories using HardyCHROM CRE for antimicrobial testing may be affected. Those handling the recalled lots (lot numbers 653594P, 655101P, 656816P) are most at risk.
Check the product label for the lot number (653594P, 655101P, or 656816P) and the expiration date (May 2025 or later). The product was manufactured between March and April 2025.
Look for the lot number on the label: 653594P, 655101P, or 656816P.
The recalled lots failed incoming quality control testing and showed breakthrough growth of Klebsiella pneumoniae bacteria.
The official recall notice does not specify a remedy for affected products.
Check the product label for lot numbers 653594P, 655101P, or 656816P, manufactured between March and April 2025.
We’ve drafted a message you can send Hardy Diagnostics to request your refund or repair — edit it as you like.
Subject: Recall Z-2041-2025 — Hardy Diagnostics Hardy Diagnostics Hello, I own a Hardy Diagnostics that is covered by recall Z-2041-2025 from Hardy Diagnostics. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
