Z-0334-2016Class II

BD CD64 APC-R700; Analyte Specific Reagent; Model 657701; Lot No. 4344945, 5037611 and 5063945. Hematology...

Name: Z-0334-2016 BD CD64 APC-R700; Analyte Specific Reagent; Model 657701; Lot No. 4344945, 5037611 and 5063945. Hematology...
Creator: Becton, Dickinson and Company, BD Biosciences
Published: 2015-10-30
License: https://open.fda.gov/license/

Becton, Dickinson and Company, BD Biosciences / initiated 2015-10-30 / Terminated / root cause: manufacturing process

FDA source

Becton, Dickinson and Company, BD Biosciences began a recall of BD CD64 APC-R700; Analyte Specific Reagent; Model 657701; Lot No. 4344945, 5037611 and 5063945. Hematology - used as analyte specific reagent - contamination... on 2015-10-30. FDA classified it as Class II and gives the reason as "Three lots of CD64 (MD22) are contaminated with CD4 antibody". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0334-2016
Classification: Class II
Status: Terminated
Initiated: 2015-10-30
Posted: 2015-11-24
Terminated: 2016-05-27
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.
Product code: MVU Reagents, Specific, Analyte
Reason for recall: Three lots of CD64 (MD22) are contaminated with CD4 antibody.
Root cause tag: manufacturing process
FDA 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 in commerce: 23 vials
Distribution: Distributed in the states of FL, WA, PA, IL, GA, RI, TX, ND, and IA.
Product codes and lots: Model 657701; Lot No. 4344945, 5037611, both with expiry date of 31 DEC 2015; and 5063945 with expiry dte of 29 FEB 2016.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0334-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0334-2016	Class II	Terminated	Voluntary: Firm initiated	2015-12-02	2015-11-24

Product code MVU

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)