Hardy Diagnostics recalls HardyCHROM MRSA G307 lot 447694 due to false positive results from MSSA breakthrough. This medium may misidentify MRSA in nasal tests.
False Positive results due to the MSSA (methicillin-susceptible) strain Staphylococcus aureus (ATCC 29213) breakthrough when this strain should have been inhibited.
Hardy Diagnostics is recalling a specific batch of HardyCHROM MRSA test medium because it can give false positive results for MRSA. This means the test might incorrectly show MRSA presence when it's actually MSSA (a different type of staph bacteria).
The test medium can allow MSSA (methicillin-susceptible Staphylococcus aureus) to grow through the test, causing it to show as MRSA when it's actually MSSA. This leads to false positive results that could mislead treatment decisions.
Lab users and healthcare professionals who test nasal samples for MRSA using this specific batch of HardyCHROM MRSA G307. Those testing with the recalled lot number 447694 are most at risk.
Check the lot number on the container, which should be 447694 for this recall. The product is labeled as HardyCHROM MRSA,REF; G307. It's a 10-plate sleeve used for nasal MRSA testing.
Look for the lot number 447694 on the container to confirm if it's affected.
The product is safe for use if the lot number is not 447694. The recall only applies to this specific batch.
The recall record does not specify a remedy for this product. Check the lot number to see if it's affected.
No, the hazard is limited to false positive test results, which do not cause physical injury.
We’ve drafted a message you can send Hardy Diagnostics to request your refund or repair — edit it as you like.
Subject: Recall Z-2298-2020 — Hardy Diagnostics Hardy Diagnostics Hello, I own a Hardy Diagnostics that is covered by recall Z-2298-2020 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.
