BioMerieux ETEST XM256 Cefuroxime Recalled for Potential Performance Issues
BioMerieux SA is recalling ETEST XM256 (Cefuroxime) antimicrobial susceptibility test strips due to potential performance issues that may result in false susceptibility or intermediate results.
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: The recall is classified as FDA Class II, and the hazard involves potential performance issues (false results) without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
BioMerieux SA is recalling 7,160 units of ETEST XM256 (Cefuroxime) antimicrobial susceptibility test strips. The recall is due to potential performance issues where the product may produce a False Susceptible result instead of Intermediate, or a False Intermediate result, when used with certain methods.
The affected product is a quantitative technique used for determining the antimicrobial susceptibility of Gram-negative and Gram-positive aerobic bacteria, including Enterobacteriaceae, Pseudomonas, Staphylococcus, and Enterococcus species, as well as fastidious bacteria. The specific reference numbers involved are 412304, 412305, 506918, and 506958.
The product was distributed worldwide, including in the United States and numerous international locations. Healthcare facilities and laboratories that use these test strips should check their inventory for the affected reference numbers and stop using the product. Users should contact BioMerieux SA for further instructions regarding the recall.
The recalled product
- Product
- ETEST XM256 (Cefuroxime), Foam: 506958-506918; SPB: 412304-412305 ETEST is a quantitative technique for determining the antimicrobial susceptibility of Gram-negative and Gram-positive aerobic bacterial such as Enterobacteriaceae, Pseudomonas, Staphylococcus and Enterococcus sp
- Manufacturer
- BioMerieux SA
- Affected units
- 7,160
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 (20)
- REF 412304 - 1004497830
- REF 412305 - 1002884720
- 1003028270
- 1003075500
- 1003383650
- 1004018820
- 1004497810
- 1005161160
- REF 506918 - 1002884980
- 1003028290
- 1003075850
- 1003385930
- 1003396150
- 1004022170
- 1004498100
- 1005161470
- REF 506958 - 1002885010
- 1003075540
- 103396550
- 1004019050
Distribution
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