Remel recalls Sensititre GN6: False susceptible results for Proteus and related bacteria when tested with certain antibiotics. Affected lots: B2247, B2096, B1445, B1263, B1176, B0503A.
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 GN6F Gram Negative IVD AST test strips because they can give false 'susceptible' results for certain bacteria when used with specific antibiotics. This could lead to incorrect treatment decisions if the test results are trusted.
The test strip may show bacteria as 'susceptible' to antibiotics when they are actually resistant. This could lead to incorrect treatment choices if the lab reports the results as accurate.
Users of this test strip for lab testing of bacteria are affected. Lab technicians and healthcare providers who use the product for clinical diagnostics are most at risk.
Check the lot number on the Sensititre GN6F test strip. Affected lots include B2247, B2096, B1445, B1263, B1176, and B0503A.
Look for the lot number on the test strip to see if it matches the affected lots listed: B2247, B2096, B1445, B1263, B1176, B0503A.
The test strip may show Proteus, Providencia, Morganella, and Morganella Morganii bacteria as susceptible to antibiotics when they are actually resistant.
The issue occurs when testing with doripenem, ertapenem, meropenem, imipenem, cefepime, piperacillin/tazobactam, and aztreonam.
Check the lot number on the Sensititre GN6F test strip. Affected lots are B2247, B2096, B1445, B1263, B1176, and B0503A.
We’ve drafted a message you can send Remel to request your refund or repair — edit it as you like.
Subject: Recall Z-0328-2023 — Remel Remel Hello, I own a Remel that is covered by recall Z-0328-2023 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.
