Thermo Scientific recalls Sensititre GN7: False susceptible results for Proteus and related bacteria when tested with specific antibiotics. Affected lot numbers listed. Contact for remedy.
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 recalls Sensititre GN7F Gram Negative IVD AST test plates that may give false results for certain bacteria when tested with specific antibiotics. This could lead to incorrect treatment decisions if used without knowing the issue.
The test plate may produce false results for specific bacteria when used with certain antibiotics. This could lead to incorrect treatment decisions if the false results are not recognized.
Users of this test plate for identifying gram-negative bacteria are affected. Those testing Proteus, Providencia, Morganella, or Morganella Morganii with doripenem, ertapenem, meropenem, imipenem, cefepime, piperacillin/tazobactam, or aztreonam are most at risk.
Check the lot number on the Sensititre GN7F plate. Affected lots include B2317, B2267, B2251, B2177, B2086, B2037, B2034B, B1476, B1424, B1384, B1286, B1215, B1182, B1104, B1051, B1021.
Look for the lot number on the Sensititre GN7F plate. Affected lots include B2317, B2267, B2251, B2177, B2086, B2037, B2034B, B1476, B1424, B1384, B1286, B1215, B1182, B1104, B1051, B1021.
The test plate may lead to false susceptible results for Proteus and related bacteria when tested with certain antibiotics, which could cause incorrect treatment decisions.
Affected lot numbers include B2317, B2267, B2251, B2177, B2086, B2037, B2034B, B1476, B1424, B1384, B1286, B1215, B1182, B1104, B1051, B1021.
The recall record does not specify a remedy, so contact Remel for further instructions.
We’ve drafted a message you can send Remel to request your refund or repair — edit it as you like.
Subject: Recall Z-0329-2023 — Remel Remel Hello, I own a Remel that is covered by recall Z-0329-2023 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.
