Product Wiki · Recalls · U.S. FDA — Device Enforcement

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 Z-0334-2016

U.S. FDA — Device Enforcement · United States · 2015-10-30 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0334-2016
Date of alert
2015-10-30
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Becton, Dickinson and Company, BD Biosciences
Product category
device
Product type
Devices
Reported risk: Three lots of CD64 (MD22) are contaminated with CD4 antibody.
Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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