BD CD3 (SK7) FITC 의 리콜

Recall

72321

Class 3

Z-0171-2016

Terminated

United States

2016-10-18

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=140615

Two lots of cd3 (sk7) fitc label contains an error in the spanish small text.

BD sent an "URGENT PRODUCT RECALL" letter dated September 30, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customer Actions: 1. Discard all remaining stock of CD3 (SK7) FITC, catalog number 349201, lot number 5148598, and/or catalog number 340542, lot number 5113983, and request replacement product. BD will replace product at no cost. 2.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). We apologize for any inconvenience that this may have caused and are working toward a long-term solution to this issue. 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.