FDAClass IIDecember 2, 2015

BD Cd64 Apc-r700 recall: Contamination

BD CD64 APC-R700; Analyte Specific Reagent; Model 657701; Lot No. 4344945, 5037611 and 5063945. Hematology - used as analyte specific reagent…

Why was BD Cd64 Apc-r700 recalled?

Three lots of CD64 (MD22) are contaminated with CD4 antibody.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Model 657701; Lot No. 4344945, 5037611, both with expiry date of 31 DEC 2015; and 5063945 with expiry dte of 29 FEB 2016.

Product
BD CD64 APC-R700; Analyte Specific Reagent; Model 657701; Lot No. 4344945, 5037611 and 5063945. Hematology - used as analyte specific reagent…
Recalling firm
Becton, Dickinson and Company, BD Biosciences
Quantity
23 vials
Distribution
Distributed in the states of FL, WA, PA, IL, GA, RI, TX, ND, and IA.
Recall date
December 2, 2015
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls