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.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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
- Affected units
- 1,917
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.
Part of a larger recall action
This product is one of 9 recalled by Remel Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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