Sensititre Medical Device Recall: False Antibiotic Susceptibility Test Results
Remel Inc. is recalling Sensititre HPB1 diagnostic plates that may produce false susceptible results for specific bacteria when tested with seven antibiotics. This could lead to inaccurate susceptibility information affecting clinical treatment decisions.
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 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.
Our severity reasoning: This is an FDA Class I recall, which the severity rubric designates as Critical. Class I recalls represent the highest level of potential public health concern due to risk of serious adverse health consequences.
Plain-English summary
Remel Inc. is recalling Sensititre HPB1 Gram Negative In Vitro Diagnostic (IVD) Antibiotic Susceptibility Test plates. Approximately 665 units have been distributed nationwide with lot numbers B2206A, B2035A, B1333, B1144A, and B0483.
An internal technical investigation confirmed that these test plates may produce false susceptible results for bacteria in the Proteae Tribe, including Proteus spp., Providencia spp., and Morganella morganii, when tested with the following antibiotics: doripenem, ertapenem, meropenem, imipenem, cefepime, piperacillin/tazobactam, and aztreonam. A false susceptible result occurs when the test indicates an organism is susceptible to an antibiotic when it is actually resistant.
Because antibiotic susceptibility test results directly inform clinical treatment decisions, false results from the recalled plates could affect the accuracy of infection management. Laboratories and healthcare facilities using these specific lot numbers should not use them for clinical testing and should contact Remel Inc. regarding this recall.
The recalled product
- Product
- Thermo SCIENTIFIC, Sensititre HPB1, Gram Negative IVD AST
- Manufacturer
- Remel Inc
- Affected units
- 665
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 (5)
- Lot Numbers: B2206A
- B2035A
- B1333
- B1144A
- B0483
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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