Recall Z-0756-2016 ยท LIB Device, General Purpose, Microbiology, Diagnostic
BioMerieux SA
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.
| Date | Feb 4, 2016 (initiated Jan 8, 2016) |
| Status | Terminated |
| Reason | Discrepant identification results related to API identification strips. These discrepant identification results are due to false negative results on the tests of the strips linked to the ZYM B reagent. |
| Root cause | Other |
| Action | BioMrieux sent an Urgent Field Safety Notice letter DATED jANUARY 8, 2015 to affected customers. The letter identified the affected product, problem and action to be taken. dated . The letter indicated that they could continue to use product in inventory with mandatory requirements that before using a ZYM B ampule and each day of use of API strips that they perform a quality control with ATCC strains as described in each package insert of involved API strips. The letter also requested that they distribute this letter to all appropriate personnel in the laboratory, retain a copy for their f |
| Quantity | 13,271 |
| Distribution | Nationwide Distribution 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, WY |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.