Medical Device Recall: ETEST Meropenem/Vaborbactam Due to Storage Temperature Excursion
Biomerieux is recalling 6 units of ETEST Meropenem/Vaborbactam susceptibility test kits (Batch 1008848690) distributed nationwide because they were stored outside specified temperature and time ranges, preventing guarantee of product 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 an FDA Class II recall with no reported illnesses, injuries, or hospitalizations. The hazard is a storage-condition failure that affects product performance reliability rather than an inherent safety defect. No adverse events have been documented.
Plain-English summary
Biomerieux Inc is recalling a limited batch of ETEST Meropenem/Vaborbactam susceptibility test kits (6 units) that were distributed nationwide. The product was stored outside specified temperature and time parameters. As a result, product performance cannot be guaranteed.
ETEST products are clinical laboratory antimicrobial susceptibility testing systems. When stored outside specification, test results cannot be reliably assured, which may affect laboratory reporting and clinical decision-making.
The recalled batch is identified as Batch Number 1008848690 (UDI/DI 03573026560690, Catalog 421560). Affected laboratories should not use the recalled product and should contact Biomerieux Inc for replacement or disposal instructions.
The recalled product
- Product
- ETEST CLINICAL ETEST MEROPENEM/VABORBACTAM MEV US S30, CATALOG 421560
- Manufacturer
- Biomerieux Inc
- Affected units
- 6
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 03573026560690
- Batch Numbers: 1008848690
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 94 recalled by Biomerieux 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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