Microbiological susceptibility test strips recalled for temperature and time excursion
Biomerieux Inc. is recalling ETEST Clinical Imipenem Relebactam test strips (Catalog 420927) distributed nationwide because the product experienced temperature and time excursions during storage. The manufacturer cannot guarantee the product's test performance.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is a Class II medical device recall without reported illnesses or injuries. The hazard is theoretical—a potential performance issue from temperature and time excursion—rather than confirmed harm. Per FDA criteria, Class II recalls without hospitalization reports and without reported incidents receive Moderate severity.
Plain-English summary
Biomerieux Inc. is recalling batch 1008988170 of ETEST Clinical Imipenem Relebactam IPR US S30 (Catalog 420927) microbiological susceptibility test strips. The product was distributed nationwide in the United States.
The recall was initiated after the product experienced temperatures and time periods outside the acceptable storage range. Under these conditions, the manufacturer cannot guarantee the product will perform as intended.
Healthcare facilities and laboratories that received this batch should discontinue use and contact Biomerieux Inc. for replacement or credit. These test strips are used to determine bacterial susceptibility to antibiotic therapy, and compromised test performance could affect clinical decisions.
The recalled product
- Product
- ETEST CLINICAL IMIPENEM RELEBACTAM IPR US S30, CATALOG 420927
- Manufacturer
- Biomerieux Inc
- Hazard
- temperature-excursion
- product-performance
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 (2)
- UDI/DI 03573026551544
- Batch Numbers: 1008988170
Distribution
Distributed nationwide across the United States.
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