BioMerieux Recalls API ZYM Bx2 Reagent Due to False Negative Results
BioMerieux SA is recalling API ZYM Bx2 reagent because it produces false negative results, leading to discrepant identification outcomes in laboratory tests.
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 involves a medical device that produces false negative results, which poses a risk of harm through misdiagnosis, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
BioMerieux SA is recalling 13,271 units of API ZYM Bx2 (Ref 70493) reagent. This product is used as an additional test to reveal the results of miniaturized biochemical tests, including those in API strips. The recall is due to discrepant identification results caused by false negative outcomes on tests linked to the ZYM B reagent.
The affected units were distributed nationwide in the states of AL, CA, CO, CT, DC, FL, GA, HI, IL, IN, IA, KS, KY, ME, MD, MA, MI, MN, MS, MO, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TX, VT, VA, WA, WV, WI, and WY. Specific lot numbers and expiration dates are listed in the recall documentation.
Laboratories and healthcare facilities should stop using the affected reagent and contact BioMerieux SA for instructions on returning or disposing of the product. Users should verify their lot numbers against the recall list to determine if their inventory is affected.
The recalled product
- Product
- API ZYM Bx2 (Ref 70493) Product Usage: ZYM B reagent is an additional test used for revealing the results of some miniaturized biochemical test including in the involved API strips.
- Manufacturer
- BioMerieux SA
- Affected units
- 13,271
Distribution
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