Recall Z-0334-2016— Becton, Dickinson and Company, BD Biosciences
Class II · Terminated
Class II FDA medical device recall by Becton, Dickinson and Company, BD Biosciences, initiated 2015-10-30, terminated 2016-05-27. FDA's recall record names no specific 510(k) clearance for this event. 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.. Reason: Three lots of CD64 (MD22) are contaminated with CD4 antibody..
- Recalling firm
- Becton, Dickinson and Company, BD Biosciences
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-10-30
- Terminated
- 2016-05-27
- Firm location
- San Jose, CA, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.