BioMerieux Recalls Ceftriaxone ETEST Kits Due to Performance Issues
BioMerieux SA is recalling Ceftriaxone ETEST kits due to a potential performance issue affecting strain categorization.
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 2/5 (Moderate).
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, but the source text explicitly states no illnesses or injuries have been reported, and the hazard is a theoretical performance issue rather than a direct physical danger.
Plain-English summary
BioMerieux SA is recalling 4,656 units of Ceftriaxone TX 32 US S30 (Ref 412302) and Ceftriaxone TX 32 US F100 (Ref 507058) ETEST kits. The recall was initiated because of a potential performance issue regarding strain categorization. ETEST is a quantitative technique used to determine the antimicrobial susceptibility of Gram-negative and Gram-positive aerobic bacteria.
The affected products were distributed nationwide in the United States, specifically to the states of AZ, AR, CA, CT, DE, FL, GA, HI, IL, LA, ME, MA, MI, MN, MO, MT, NH, NY, NC, OR, PA, SC, SD, TN, TX, and WA. Specific lot codes for Ref 412302 include 1002939460, 1003361690, 1003848910, 1004041770, 1004394530, 1004731200, 1004876830, and 1005327130. Specific lot codes for Ref 507058 include 1002940890, 1003128150, 1003361950, 1003849820, 1004041790, 1004239890, 1004395510, 1004525370, 1004756050, 1004828430, 1004876860, and 1004919030.
Healthcare facilities and laboratories should stop using these kits and contact BioMerieux SA for instructions on returning the products. The source text does not report any illnesses or injuries associated with this recall.
The recalled product
- Product
- Ceftriaxone TX 32 US S30, Ref 412302 and Ceftriaxone TX 32 US F100, Ref 507058 ETEST is a quantitative technique for determining the antimicrobial susceptibility of Gram-negative and Gram-positive aerobic ba
- Manufacturer
- BioMerieux SA
- Affected units
- 4,656
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 412302 1002939460
- 1003361690
- 1003848910
- 1004041770
- 1004394530
- 1004731200
- 1004876830
- 1005327130
- Ref 507058 1002940890
- 1003128150
- 1003361950
- 1003849820
- 1004041790
- 1004239890
- 1004395510
- 1004525370
- 1004756050
- 1004828430
- 1004876860
- 1004919030
Distribution
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