Reported Dec 2, 2015 · Terminated

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

Becton, Dickinson and Company, BD Biosciences

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Becton, Dickinson and Company, BD Biosciences · 2350 Qume Dr · San Jose, CA · 95131-1812

Is this the product you have?

  • 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.
Lot codes and dates
    • Model 657701
    • Lot No. 4344945
    • 5037611
    • both with expiry date of 31 DEC 2015
    • and 5063945 with expiry dte of 29 FEB 2016
Amount recalled
23 vials

Where it was sold

Why it was recalled

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

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated May 27, 2016 · Data as of Sep 19, 6:01 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.