Reported Aug 17, 2016 · Terminated

BD Tritest CD3 FITC/CD4 PE/CD45 PerCP (IVD); Catalog number 340383. Label states: Contains CD3 FITC/CD4 PE/CD45 per CP…

Becton, Dickinson and Company, BD Biosciences

Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.

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 Tritest CD3 FITC/CD4 PE/CD45 PerCP (IVD)
    • Catalog number 340383
  • Label statesContains CD3 FITC/CD4 PE/CD45 per CP with Gelatin and 0.1% sodium azide
  • HematologyBD Tritest CD3 fluorescein isothiocyanate (FITC)/CD4 phycoerythrin (PE)/CD45 peridinin chlorophyll protein (PerCP) is a three-color direct immunofluorescence reagent for use with a suitably equipped flow cytometer to identify and determine the percentages and absolute counts of mature human T lymphocytes (CD3+) and helper/inducer (CD3+CD4+) Tlymphocyte subsets in erythrocyte-lysed whole blood
Lot codes and dates
  • Catalog number
    • 340383
    • lot No. Expiration Date 49983
    • 31 July 2016
    • 01810
    • 30 September 2016
    • 82527
    • 30 September 2016
    • 54689
    • 30 November 2016
    • 36715
    • 31 December 2016
    • 15614
    • 31 January 2017
    • 57797
    • 28 February 2017
Amount recalled
14,089

Where it was sold

Why it was recalled

Internal review found that some vials of CD3/CD4/CD45 state that the product contains gelatin. The product does not contain gelatin and should state in buffer.

This product is unlikely to cause harm, but it breaks a safety or labelling rule.

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Where this came from

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

Read the FDA (openFDA device enforcement) notice

Notice updated Mar 1, 2017 · Data as of Sep 19, 6:06 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.