Recall Z-0628-2016 ยท MVU Reagents, Specific, Analyte
Becton, Dickinson and Company, BD Biosciences
FMC7 FITC, Catalog No. 340918 Analyte Specific Reagent.
| Date | Jan 11, 2016 (initiated Dec 14, 2015) |
| Status | Terminated |
| Reason | Becton, Dickinson and Company (BD) has determined that the FMC7 FITC (ASR) is exhibiting functional degradation. The functional degradation has the effect of reducing the percent positive from 100% down to approximately 87%. |
| Root cause | Under Investigation by firm |
| Action | BD Biosciences sent an Urgent Product Recall letter dated December 2015, to all affected customers to inform them that Becton, Dickinson and Company (BD) has determined that the FMC7 FITC (ASR) is exhibiting functional degradation. The letter informs the customers of the problems identified and the actions to be taken. Customers are instructed to return the Tracking/Verification form to BD Biosciences. Customers are instructed to contact BD Customer Support at (877) 232-8995 (prompt 3, 3) in the US. Customers outside of the US are instructed to contact their local BD Biosciences or distribu |
| Quantity | 1,388 units |
| Distribution | Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.