Thermo Sensititre diagnostic plate recalled for false susceptibility results
Sensititre diagnostic plates may give false antibiotic susceptibility results for certain bacteria species, potentially affecting treatment decisions. The FDA issued a Class I recall for approximately 1,917 units distributed nationwide.
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: FDA Class I classification applies to this recall, requiring a minimum severity score of 4. While no illnesses have been reported, false diagnostic results could lead to inappropriate antibiotic selection in clinical practice.
Plain-English summary
Thermo Scientific Sensititre Plate, GN4F is a diagnostic testing plate used in clinical laboratories. The FDA recalled approximately 1,917 units due to a potential defect in test accuracy.
The plates may produce false susceptible results when testing certain Proteae bacteria—including Proteus, Providencia, and Morganella morganii species—against doripenem, ertapenem, meropenem, imipenem, cefepime, piperacillin/tazobactam, and aztreonam. False results could lead to inappropriate antibiotic selection.
The affected lot numbers are B2232B, B2197, B2012, B1355, B1181, B1173, and B1125A, distributed nationwide. Clinical laboratories using affected lots should discontinue use and contact Remel Inc for replacement or refund.
The recalled product
- Product
- Thermo SCIENTIFIC Sensititre Plate, GN4F, Gram Negative IVD AST
- Manufacturer
- Remel Inc
- Hazard
- false-susceptible-result
- diagnostic-inaccuracy
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 (7)
- Lot Numbers: B2232B
- B2197
- B2012
- B1355
- B1181
- B1173
- B1125A
Distribution
Distributed nationwide across the United States.
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