Hardy Diagnostics recalls Brain Heart Infusion Agar with 6 ug/ml Vancomycin (Lot 472698) due to Staphylococcus aureus breakthrough. Affected users should check their lot numbers and contact the company for details.
Complaints were received reporting of Staphylococcus aureus (ATCC 29213) breakthrough when the strain should have been inhibited.
Hardy Diagnostics is recalling Brain Heart Infusion Agar with 6 ug/ml Vancomycin (Lot 472698) because it failed to inhibit Staphylococcus aureus growth. This could lead to inaccurate lab results if used in microbiology testing.
The agar failed to prevent Staphylococcus aureus (a common bacteria) from growing, which could cause false positive results in lab tests. This happens because the vancomycin concentration was insufficient to block the bacteria.
Lab users and microbiology researchers who purchased the specific lot (472698) from Hardy Diagnostics. Those using the product for bacterial culture testing are most at risk.
Check for the lot number 472698 on the container. The product was manufactured on October 29, 2020, and expired December 28, 2020. It comes in 15x100mm plates with 18 ml of agar.
Look for the lot number 472698 on the container to confirm if it is affected.
The product may not inhibit Staphylococcus aureus growth, so it could lead to inaccurate lab results. Use only the unaffected lot numbers.
The recall record does not specify a replacement process or contact information.
The recall record does not state a specific action for affected users beyond checking the lot number.
We’ve drafted a message you can send Hardy Diagnostics to request your refund or repair — edit it as you like.
Subject: Recall Z-0919-2021 — Hardy Diagnostics Hardy Diagnostics Hello, I own a Hardy Diagnostics that is covered by recall Z-0919-2021 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.
