Medical Device Recall: Sensititre Test Produces False Antibiotic Susceptibility Results
Remel Inc. is recalling a diagnostic test that may incorrectly report antibiotic susceptibility in certain Gram-negative bacteria. False results could lead to inappropriate antibiotic treatment.
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: This is an FDA Class I medical device recall. Although no illnesses or injuries have been reported, the Class I designation indicates a reasonable probability that the defect could cause serious adverse health consequences through incorrect antibiotic susceptibility testing results.
Plain-English summary
Remel Inc. is recalling the Thermo SCIENTIFIC Sensititre STP7F Gram Negative in vitro diagnostic test, which is used to determine antibiotic susceptibility in certain bacteria.
An internal technical investigation confirmed that this test may produce false susceptible results when testing specific Gram-negative bacteria, particularly those in the Proteae tribe, against seven antibiotics: doripenem, ertapenem, meropenem, imipenem, cefepime, piperacillin/tazobactam, and aztreonam. A false susceptible result indicates the test incorrectly shows bacteria as susceptible when they may actually be resistant to the antibiotic.
The affected product (lot B2265A) has been distributed nationwide in the United States. Laboratories and healthcare facilities using this product should verify they do not have affected product and contact Remel Inc. for further guidance.
The recalled product
- Product
- Thermo SCIENTIFIC, Sensititre STP7F, Gram Negative IVD AST
- Manufacturer
- Remel Inc
- Category
- Medical Device — Diagnostic Test
- Affected units
- 9
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 (1)
- Lot Numbers: B2265A
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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