Remel recalls Sensititre HPB1 Gram Negative IVD AST lot numbers B2206A, B2035A, B1333, B1144A, B048: May cause 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 Sensititre HPB1 Gram Negative IVD AST test kits with specific lot numbers. These kits may give false results for certain bacteria when tested with specific antibiotics, which could lead to incorrect treatment decisions.
The test kits may produce false 'susceptible' results for specific bacteria when used with certain antibiotics. This means the test might incorrectly indicate that bacteria are sensitive to antibiotics when they are actually resistant, potentially leading to inappropriate treatment choices.
Users of these test kits for identifying bacteria in clinical labs are affected. Those testing for Proteus, Providencia, Morganella, or Morganella Morganii may be at risk of incorrect results.
Check the lot number on the Sensititre HPB1 Gram Negative IVD AST test kit. Affected lots are B2206A, B2035A, B1333, B1144A, and B0483.
Identify the lot number on your Sensititre HPB1 Gram Negative IVD AST test kit to see if it is one of the affected lots: B2206A, B2035A, B1333, B1144A, or B0483.
The test kits may produce false 'susceptible' results for Proteus and related bacteria when tested with certain antibiotics, which could lead to incorrect treatment decisions.
Affected lot numbers are B2206A, B2035A, B1333, B1144A, and B0483.
No specific stop-use instruction is provided in the recall notice. Affected users should check their lot number and consider using a different kit if the lot number matches the affected ones.
We’ve drafted a message you can send Remel to request your refund or repair — edit it as you like.
Subject: Recall Z-0330-2023 — Remel Remel Hello, I own a Remel that is covered by recall Z-0330-2023 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.
