Thermo Scientific Sensititre CMC7AFL: False susceptible results for certain bacteria with specific antibiotics. Recall covers specific lot numbers.
An internal technical investigation has confirmed that Thermo Scientific" Gram Negative IVD AST Sensititre Plate may lead to false susceptible results for Proteae Tribe (including Proteus spp., Providencia spp., Morganella Morganii) when tested with doripenem, ertapenem, meropenem, imipenem, cefepime, piperacillin/tazobactam and aztreonam.
Remel's Sensititre CMC7AFLF Gram Negative IVD AST test plates may give false 'susceptible' results for certain bacteria when tested with specific antibiotics. This could lead to incorrect treatment decisions if used without the recall fix.
The test plates may incorrectly show bacteria as 'susceptible' to certain antibiotics when they are actually resistant. This could lead to inappropriate antibiotic use if the test results are trusted without correction.
Users of this bacterial test kit, particularly labs testing for Proteus, Providencia, Morganella, or Morganella Morganii. Those using the kit with doripenem, ertapenem, meropenem, imipenem, cefepime, piperacillin/tazobactam, or aztreonam are most at risk.
Check for lot numbers B2281, B2151A, B2034, or B1453 on the Sensititre CMC7AFLF Gram Negative IVD AST test plates. These are the specific lots recalled by Remel.
Look for lot numbers B2281, B2151A, B2034, or B1453 on the Sensititre CMC7AFLF Gram Negative IVD AST test plates.
The test plates may lead to false susceptible results for certain bacteria when tested with specific antibiotics, potentially causing incorrect treatment decisions.
Check the lot number on the product. If it matches B2281, B2151A, B2034, or B1453, contact Remel for guidance.
The recall record does not specify a remedy or fix for this issue.
We’ve drafted a message you can send Remel to request your refund or repair — edit it as you like.
Subject: Recall Z-0332-2023 — Remel Remel Hello, I own a Remel that is covered by recall Z-0332-2023 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.
