BD CD64 APC-R700; Analyte Specific Reagent; Model 657701; Lot No. 4344945, 5037611 and 5063945. Hematology - used as analyte specific reagent - contamination leads to possibility of unexpected staining pattern.
- Recall Initiated
- October 30, 2015
- Terminated
- May 27, 2016
- Recall Number
- Z-0334-2016
- Quantity
- 23 vials
- Firm Location
- San Jose, CA
Reason for Recall
Three lots of CD64 (MD22) are contaminated with CD4 antibody.
Distribution
Distributed in the states of FL, WA, PA, IL, GA, RI, TX, ND, and IA.
Lot / Code Info
Model 657701; Lot No. 4344945, 5037611, both with expiry date of 31 DEC 2015; and 5063945 with expiry dte of 29 FEB 2016.
Root Cause
Process control
Action Taken
Urgent Product Recall letters were sent out on October 30, 2015 via certified mail to notify customers of the issue.
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