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.
Reported: December 2, 2015 Initiated: October 30, 2015 #Z-0334-2016
Product Description
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.
Reason for Recall
Three lots of CD64 (MD22) are contaminated with CD4 antibody.
Details
- Recalling Firm
- Becton, Dickinson and Company, BD Biosciences
- Units Affected
- 23 vials
- Distribution
- Distributed in the states of FL, WA, PA, IL, GA, RI, TX, ND, and IA.
- Location
- San Jose, CA
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Becton, Dickinson and Company, BD Biosciences. Units affected: 23 vials.
Why was this product recalled? ▼
Three lots of CD64 (MD22) are contaminated with CD4 antibody.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 2, 2015. Severity: Moderate. Recall number: Z-0334-2016.
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