FDA Class I Recall: Thermo Sensititre Gram Negative Diagnostic Test Inaccuracy
Thermo Scientific Sensititre CMC7AFLF Gram Negative diagnostic tests may produce false susceptible results for certain bacteria, potentially leading to ineffective antibiotic treatment decisions. The FDA has classified this as a Class I recall.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class I recall of an in vitro diagnostic device. Per the rubric, FDA Class I recalls must score at least 4 (Severe). The product defect can produce clinically significant false results that may lead to inappropriate antibiotic therapy.
Plain-English summary
Remel Inc is recalling the Thermo Scientific Sensititre CMC7AFLF Gram Negative IVD AST diagnostic test. This in vitro diagnostic test is used in clinical laboratories to determine bacterial susceptibility to antibiotics. The recall involves 1,647 units distributed nationwide, with affected lot numbers B2281, B2151A, B2034, and B1453.
An internal technical investigation identified a defect: the test may produce false susceptible results when testing certain gram-negative bacteria for susceptibility to specific antibiotics. The affected bacteria are part of the Proteae tribe, including Proteus spp., Providencia spp., and Morganella morganii. The affected antibiotics are doripenem, ertapenem, meropenem, imipenem, cefepime, piperacillin/tazobactam, and aztreonam.
If the test incorrectly reports susceptibility, a clinician may select an antibiotic that is actually ineffective against the patient's infection. Healthcare providers and clinical laboratories should review the use of affected lots and consider retesting samples if this product was used for patient care. Contact the manufacturer for guidance on managing affected test results.
The recalled product
- Product
- Thermo SCIENTIFIC, Sensititre CMC7AFLF, Gram Negative IVD AST
- Manufacturer
- Remel Inc
- Hazard
- diagnostic-inaccuracy
- false-susceptible-result
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- Lot Numbers: B2281
- B2151A
- B2034
- B1453
Distribution
Distributed nationwide across the United States.
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