Remel recalls Todd Hewitt Broth (lot 668255) used for Group B Strep testing due to potential false negatives in QC tests. Affected units may not detect target bacteria correctly.
On lot of Todd Hewitt Broth w/CNA (LIM) may exhibit no recovery of target organism during customer QC testing or use with patient samples
Remel is recalling a specific batch of Todd Hewitt Broth used to test for Group B Strep in clinical samples. This batch may fail to detect the target bacteria during quality checks, leading to incorrect test results.
The recalled batch may not show recovery of the target bacteria during quality control tests. This could cause false negative results when used with patient samples, potentially missing infections.
Laboratory users who purchased the recalled batch (lot 668255) of Todd Hewitt Broth for Group B Strep testing. Those using the product for clinical specimens are most at risk of inaccurate results.
Check for the lot number 668255 on the packaging. The product is labeled as Todd Hewitt W. CNA (LIM) Broth with expiration date 04/26/2024.
Look for lot number 668255 on the packaging to confirm if your product is affected.
The recalled batch may not show recovery of the target bacteria during quality control tests, leading to false negative results in Group B Strep testing.
Check the lot number on the packaging. If it's 668255, contact Remel for guidance.
No, this is a laboratory product that does not pose a physical safety risk. The hazard is limited to inaccurate test results.
We’ve drafted a message you can send Remel to request your refund or repair — edit it as you like.
Subject: Recall Z-2531-2023 — Remel Remel Hello, I own a Remel that is covered by recall Z-2531-2023 from Remel. 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.