Device Recall BD ReticCount" Reticulocyte Reagent System 의 리콜

Recall

73597

Class 3

Z-1390-2016

2016-03-18

Terminated

United States

2016-12-02

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=144551

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.

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 complete the enclosed Tracking/Verification form , even if you no longer have the affected reagents listed in your inventory. Please return the Tracking/Verification form to BD Biosciences, per the instructions (mail, fax, or email). If you require further assistance, please contact BD Customer Support at 877.232.8995 (prompt 3, 3) in the United States. For customers outside the US, contact your local BD Biosciences representative or distributor.