Thermo Scientific recalls Sensititre C: Gram Negative IVD AST test kits with lot numbers B2125 and B2115 due to potential false susceptible results for certain 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.
Thermo Scientific is recalling Sensititre CMC5VGNF Gram Negative IVD AST test kits with lot numbers B2125 and B2115. These kits may produce false susceptible results for certain bacteria when tested with specific antibiotics, which could lead to incorrect treatment decisions.
The test kits may show bacteria as susceptible to antibiotics when they are actually resistant. This could lead to incorrect treatment choices if the test results are used to decide antibiotic therapy. The false results are specific to certain bacteria and antibiotics.
Users of these test kits for identifying gram-negative bacteria in clinical labs are affected. Those testing for Proteus, Providencia, Morganella, or Morganella Morganii with specific antibiotics are at risk of incorrect results.
Check the lot number on the Sensititre CMC5VGNF test kit. Lot numbers B2125 and B2115 are affected. These kits are sold by Thermo Scientific for gram-negative bacterial identification.
Identify the lot number on the Sensititre CMC5VGNF test kit to determine if it is affected (B2125 or B2115).
These kits may produce false susceptible results for Proteus, Providencia, Morganella, and Morganella Morganii when tested with certain antibiotics like doripenem, ertapenem, meropenem, imipenem, cefepime, piperacillin/tazobactam, and aztreonam.
Check the lot number on the test kit. If it is B2125 or B2115, contact Thermo Scientific for guidance on next steps.
The recall only affects Sensititre CMC5VGNF Gram Negative IVD AST test kits with lot numbers B2125 and B2115.
We’ve drafted a message you can send Remel to request your refund or repair — edit it as you like.
Subject: Recall Z-0331-2023 — Remel Remel Hello, I own a Remel that is covered by recall Z-0331-2023 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
