Remel recalls Sensititre STP7F Gram Negative IVD AST due to false susceptible results for Proteus and related bacteria when tested with specific antibiotics.
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 its Sensititre STP7F Gram Negative IVD AST test plates because they can give false results for certain bacteria when used with specific antibiotics. This could lead to incorrect treatment decisions if the test is not properly interpreted.
The test plates can produce false results for Proteus and related bacteria when tested with certain antibiotics like doripenem, ertapenem, meropenem, imipenem, cefepime, piperacillin/tazobactam, and aztreonam. This means the test might incorrectly show bacteria as susceptible to antibiotics when they are actually resistant, potentially leading to inappropriate treatment choices.
Users of the Sensititre STP7F Gram Negative IVD AST test plates are affected. Laboratory technicians and healthcare professionals who perform bacterial susceptibility testing are most at risk.
Check for the Sensititre STP7F Gram Negative IVD AST product name. The affected lot number is B2265A.
Identify the product name and lot number to confirm if it is affected.
The test plates can produce false susceptible results for Proteus and related bacteria when tested with certain antibiotics like doripenem, ertapenem, meropenem, imipenem, cefepime, piperacillin/tazobactam, and aztreonam.
Lot number B2265A is affected.
The recall does not require immediate stop use; check the product details to confirm if it is affected.
We’ve drafted a message you can send Remel to request your refund or repair — edit it as you like.
Subject: Recall Z-0335-2023 — Remel Remel Hello, I own a Remel that is covered by recall Z-0335-2023 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.
