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Recall Observatory FDA recall evidence

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

October 30, 2015

Class II

Product summary

Firm
Becton, Dickinson and Company, BD Biosciences
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

    reason.no_named_rule · v1.0.0

    Three lots of CD64 (MD22) are contaminated with CD4 antibody.