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Recall Observatory FDA recall evidence

Device product

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

Z-2252-2016

June 24, 2016

Class II

Product summary

Firm
Becton, Dickinson and Company, BD Biosciences
Event
Event 74537
Status
Terminated
Classification
Class II
Quantity
328 US, 516 International
Official record key
device-enforcement:Z-2252-2016

Official wording

Reason: 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.

Code information: Catalog 340334, Lot ;6083708 (embossing ID of (160216T3)

Distribution pattern: 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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.