Recall Z-1477-2014 ยท LIB Device, General Purpose, Microbiology, Diagnostic
BioMerieux SA
API NIH (REF 10400). ZYM B reagent is used and included inside of API NH (REF 10400) and API Listeria (10300). All of the API's are standardized systems combining several biochemical tests that enable group or species identification of most microorganisms.
| Date | Apr 18, 2014 (initiated Mar 6, 2014) |
| Status | Terminated |
| Reason | bioMerieux identified a visual defect and activity issue on the ZYM B reagent (REF 70493) and FB reagent (REF 70562). The activity issue lead to a false negative result of some Rapid ID 32 strips and API biochemical tests using the ZYM B reagent or FB reagent |
| Root cause | Other |
| Action | Letters were issued to customers on March 10, 2014. The letter contained instructions to be used if they still were using the product. The letter also included a report form which was to be returned. |
| Quantity | 33,853 |
| Distribution | Worldwide Distribution-USA (nationwide) including DC and Puerto Rico, and the states of AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VT, VA, WV, WA, WI, and WY and the |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.