Device product
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.
Z-0334-2016
Product summary
- Event
- Event 72548
- Status
- Terminated
- Classification
- Class II
- Quantity
- 23 vials
- Official record key
device-enforcement:Z-0334-2016
Official wording
Reason: Three lots of CD64 (MD22) are contaminated with CD4 antibody.
Code information: Model 657701; Lot No. 4344945, 5037611, both with expiry date of 31 DEC 2015; and 5063945 with expiry dte of 29 FEB 2016.
Distribution pattern: Distributed in the states of FL, WA, PA, IL, GA, RI, TX, ND, and IA.
Derived failure modes
-
Unknown
Three lots of CD64 (MD22) are contaminated with CD4 antibody.