BioMerieux Etest Cefotaxime CT 256 In Vitro Diagnostic Recall
BioMerieux SA is recalling Etest Cefotaxime CT 256 in vitro diagnostic devices because quality control results were out of range, potentially causing false resistant strain results.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II and involves a risk of harm (false resistant strain results) without reported injuries or illnesses, meeting the criteria for a High severity score.
Plain-English summary
BioMerieux SA is recalling 674 units of Etest Cefotaxime CT 256 WW and Etest Cefotaxime CT 256 US in vitro diagnostic devices. The recall was initiated because quality control results were out of range, which resulted in false resistant strains.
The affected products were distributed worldwide, including nationwide in the United States to specific states and to numerous international countries. The recall is classified as Class II by the U.S. Food and Drug Administration.
Healthcare facilities and laboratories should stop using the affected Etest Cefotaxime CT 256 devices and contact BioMerieux SA for instructions on how to return or dispose of the products.
The recalled product
- Product
- Etest Cefotaxime CT 256 WW and Etest Cefotaxime CT 256 US. in vitro diagnostic.
- Manufacturer
- BioMerieux SA
- Affected units
- 674
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)
- 1002774320
- 1002377890
- 1002590470
- 1002775330
- 1002379610
Distribution
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