Recall Z-0851-2016 ยท MVU Reagents, Specific, Analyte
Becton, Dickinson and Company, BD Biosciences
BD FMC7 FITC: Model 430918. FMC7 is intended for in vitro diagnostic use in the identification of cells expressing FMC7 antigen. Product Usage: Analyte Specific Reagent. FMC7 is intended for in vitro diagnostic use in the identification of cells expressing FMC7 antigen.
| Date | Jan 25, 2016 |
| Status | Terminated |
| Reason | Becton, Dickinson and Company (BD) has determined that the FMC7 FITC (ASR) has an incorrect expiration date listed on the vial label. |
| Root cause | Under Investigation by firm |
| Action | BD Biosciences sent an Urgent Medical Device Recall letters dated January 2016 via certified mail to affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed that the remaining stock of the product can be used until 6-30-16. however, if prefer they can discard all remaining stock of the affected lot and BD will replace. The letter request customers complete the Tracking/verification form and returned to BD Biosciences, per the instructions (mail, fax, or email). For questions contact your local BD representative or BD Custome |
| Quantity | 78 |
| Distribution | Worldwide Distribution - US Nationwide in the staates of TX, NY, GA, NJ, AL, MA, IL, PA, DC, FL, CA, MD, OK. and coutry of Taiwan. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.