Reported May 4, 2016 · Terminated

BD Trucount Absolute Counting Tubes: Model number: 340334 IVD; BD Trucount tubes are used for determining absolute…

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 Trucount Absolute Counting TubesModel
  • number340334 IVD; BD Trucount tubes are used for determining absolute counts of leucocytes in blood. BD Trucount tubes are designed for use with in vitro diagnostic products such as BD Tritest reagents, and a suitably equipped flow cytometer. BD Trucount tubes can be used with the BD FACS Loader
Lot codes and dates
  • Model340334
  • Manufacaturing lot534964
Amount recalled
1743; 467 US and 1276 International

Where it was sold

Why it was recalled

One lot of lot of BD Trucount tubes may contain tubes from another lot. There is a 3.3% difference in bead counts between the two lots found within some of the pouches and presents a low risk to patient safety or impact to data if this product is used.

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 26, 2017 · Data as of Sep 19, 5:21 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.