The Recall Desk

FDA (Devices) recall action 90866

Becton, Dickinson and Company, BD Biosciences recalled 3 products on 2022-11-09

The FDA (Devices) publishes a recall like this one as 3 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 3 pages.

Products
3
Announced
2022-11-09
Critical
0
Units
—

Why these products were recalled

Due to partial label detachment on tubes. This can cause tubes to become stuck together in the pouch or cause automation errors when used with the automated loader for the wash assistant.

Due to partial label detachment on tubes. This can cause tubes to become stuck together in the pouch or cause automation errors when used with the automated loader for the wash assistant. Firm root cause investigation confirmed that label detachment is due to an adhesive change by a tier 2 supplier.

Due to partial label detachment on tubes. This can cause tubes to become stuck together in the pouch or cause automation errors when used with the automated loader for the wash assistant. Firm root cause investigation confirmed that label detachment is due to an adhesive change by a tier 2 supplier.

The agency’s own wording, quoted from the enforcement report.

States named across these recalls

1–3 of 3

  • ModerateFDA (Devices)··2022-11-09

    BD Multitest 6-Color TBNK tubes recalled for partial label detachment

    BD Multitest 6-Color TBNK tubes are being recalled due to partial label detachment. The defect can cause tubes to stick together or lead to automation errors when used with the flow cytometer's automated loader.

    Product
    BD Multitest 6-Color TBNK with optional BD Trucount Tubes (Cat. No. 662995), for use with BD FACSLyric, BD FACSCanto II, and BD FACSCanto flow cytometers to determine the percentages and absolute counts of human lymphocyte subsets in peripheral whole blood for immunophenotyping.
    Category
    Distribution
    43 states
  • HighFDA (Devices)··2022-11-09

    BD Trucount Tubes Recalled Due to Partial Label Detachment Causing Operational Failures

    Becton Dickinson is recalling BD Trucount Tubes due to partial label detachment that can cause tubes to stick together in pouches or fail when used with automated loaders. No illnesses have been reported.

    Product
    BD Trucount Tubes (Cat. No. 663028), used for determining absolute counts of leukocytes 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 B
    Category
    Distribution
    43 states
  • HighFDA (Devices)··2022-11-09

    BD Trucount Tubes for Blood Testing Recall Due to Label Detachment

    Becton, Dickinson is recalling BD Trucount Tubes due to partial label detachment that can cause tubes to stick together or create automation errors. The defect stems from an adhesive supplier change and affects 52,570 units.

    Product
    BD Trucount Tubes (Cat. No. 340334), 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 B
    Category
    Distribution
    43 states