Thermo Scientific Remel recalls Sensititre Plate GN4: False susceptible results for Proteus bacteria when tested with specific antibiotics. Affected lot numbers listed. No remedy provided in recall notice.
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 is recalling Sensititre Plate GN4F Gram Negative IVD AST products that may give false susceptible results for certain bacteria when tested with specific antibiotics. This could lead to incorrect treatment decisions if used in clinical testing.
The product may show bacteria as 'susceptible' to antibiotics when they are actually resistant. This could lead to incorrect treatment decisions if used in clinical testing. The false results occur with specific antibiotics like doripenem and meropenem.
Laboratory users testing bacteria cultures with this product are most at risk. The recall affects specific lot numbers of the Sensititre Plate GN4F.
Check for lot numbers B2232B, B2197, B2012, B1355, B1181, B1173, or B1125A on the Sensititre Plate GN4F Gram Negative IVD AST product.
Look for lot numbers B2232B, B2197, B2012, B1355, B1181, B1173, or B1125A on the product.
The recall notice does not provide a remedy.
Lot numbers B2232B, B2197, B2012, B1355, B1181, B1173, and B1125A.
The product may show bacteria as 'susceptible' to certain antibiotics when they are actually resistant, leading to incorrect treatment decisions.
We’ve drafted a message you can send Remel to request your refund or repair — edit it as you like.
Subject: Recall Z-0327-2023 — Remel Remel Hello, I own a Remel that is covered by recall Z-0327-2023 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.
