Recall Z-1390-2016 ยท GKL Counter, Cell, Automated (Particle Counter)
Becton, Dickinson and Company, BD Biosciences
BD-Retic-Count Reticulocyte Reagent System; Hematology: Used for in vitro diagnostics
| Date | Mar 18, 2016 |
| Status | Terminated |
| Reason | The carton label for one lot of BD Retic-Count Reticulocyte Reagent System had the incorrect storage conditions. The labels on the reagent as well as the Instructions for Use are correct. |
| Root cause | Under Investigation by firm |
| Action | BD Biosciences sent an Urgent Product Recall letter on March 18, 2016, to all affected customers by certified mail. The letter identified the product the problem and the action needed to be taken by the customer. Customer Actions: 1. Examine your data files obtained using reagents from the affected lots for low performance. 2. Discard all remaining stock of BD Retic-Counter reticulocyte reagent system, Catalog Number 349204, lot number 5175559, and request replacement product. BD will replace product at no cost. 3. As a requirement of our Regulatory Tracking Process, we request that you comp |
| Quantity | 205 |
| Distribution | Worldwide Distribution - US Distribution to the states of : CT, MN, FL, NY, CA, MA, DC, UT, VA and IN., and to the countries of : Belgium, Brazil, Canada, China, India, Japan, Korea, Singapore and Taiwan. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K880636 | RETICCOUNT SOFTWARE Bd Becton Dickinson Vacutainer Systems Preanalytic, Mar 21, 1988 |