PlainRecalls
FDA Devices Moderate Class II Terminated

BD Trucount Tubes: Catalog number: 340334 Hematology: BD Trucount tubes are used for determining absolute counts of leucocytes in blood.

Reported: July 27, 2016 Initiated: June 24, 2016 #Z-2252-2016

Product Description

BD Trucount Tubes: Catalog number: 340334 Hematology: BD Trucount tubes are used for determining absolute counts of leucocytes in blood.

Reason for Recall

One lot of BD Trucount Absolute Counting Tubes (IVD) may not be sealed properly and exposure to ambient environment can rapidly degrade the performance of the product.

Details

Units Affected
328 US, 516 International
Distribution
USA Distribution to the states of : NC, WA, WI, NJ, PR, MD, NY, MA, CA, NY , MD, KY, IN, VA, SD, PA, OH, AR, AZ and Foreign to : Canada, Belgium and Chile
Location
San Jose, CA

Frequently Asked Questions

What product was recalled?
BD Trucount Tubes: Catalog number: 340334 Hematology: BD Trucount tubes are used for determining absolute counts of leucocytes in blood.. Recalled by Becton, Dickinson and Company, BD Biosciences. Units affected: 328 US, 516 International.
Why was this product recalled?
One lot of BD Trucount Absolute Counting Tubes (IVD) may not be sealed properly and exposure to ambient environment can rapidly degrade the performance of the product.
Which agency issued this recall?
This recall was issued by the FDA Devices on July 27, 2016. Severity: Moderate. Recall number: Z-2252-2016.