Thermo Scientific recalls Sensititre MDRGN3: False susceptible results for Proteus and related bacteria when tested with specific antibiotics. Affected units have lot number B2311B.
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.
Thermo Scientific is recalling Sensititre MDRGN3F Gram Negative IVD AST test plates because they can give false 'susceptible' results for certain bacteria when tested with specific antibiotics. This could lead to incorrect treatment decisions if used without knowing the issue.
The test plates can produce false results that show bacteria as 'susceptible' to antibiotics when they are actually resistant. This could lead to incorrect treatment choices if the lab uses the results without realizing the problem.
Users of this bacterial test kit, particularly labs testing for Proteus and related bacteria, may be affected. Those using the kit with doripenem, ertapenem, meropenem, imipenem, cefepime, piperacillin/tazobactam, or aztreonam are most at risk.
Check for the lot number B2311B on the Sensititre MDRGN3F Gram Negative IVD AST test plates. The product is sold by Thermo Scientific.
Look for lot number B2311B on the Sensititre MDRGN3F Gram Negative IVD AST test plates.
The test plates can produce false 'susceptible' results for Proteus and related bacteria when tested with certain antibiotics, which could lead to incorrect treatment decisions.
Check the lot number on the product; if it's B2311B, contact Thermo Scientific for guidance.
No, this is a laboratory test kit issue that does not pose a physical injury risk.
We’ve drafted a message you can send Remel to request your refund or repair — edit it as you like.
Subject: Recall Z-0333-2023 — Remel Remel Hello, I own a Remel that is covered by recall Z-0333-2023 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.
