FDA Medical Device Recalls (openFDA)
Becton, Dickinson and Company, BD Biosciences: 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 number
- Z-0334-2016
- Recalling firm
- Becton, Dickinson and Company, BD Biosciences
- 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.
- Status
- Terminated
- Initiated
- 2015-10-30
- Posted
- not on file
- Terminated
- 2016-05-27
- Reason
- Three lots of CD64 (MD22) are contaminated with CD4 antibody.
- Root cause
- Process control
- Action
- Urgent Product Recall letters were sent out on October 30, 2015 via certified mail to notify customers of the issue.
- Quantity
- 23 vials
- Distribution
- Distributed in the states of FL, WA, PA, IL, GA, RI, TX, ND, and IA.
- Lot, serial or model codes
- Model 657701; Lot No. 4344945, 5037611, both with expiry date of 31 DEC 2015; and 5063945 with expiry dte of 29 FEB 2016.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- MVU
- Firm FEI
- 2916837
- Firm city
- San Jose
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28