The Recall Desk

FDA (Devices) recall action 90028

Becton, Dickinson and Company, BD Biosciences recalled 2 products on 2022-06-08

The FDA (Devices) publishes a recall like this one as 2 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 2 pages.

Products
2
Announced
2022-06-08
Critical
0
Units
448

Why these products were recalled

Anti-Kappa APC & Anti-Kappa PE analyte reagents may exhibit uncharacteristic flow profiles.

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

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–2 of 2

  • ModerateFDA (Devices)··2022-06-08

    BD Anti-Kappa Flow Cytometry Reagents Recalled for Uncharacteristic Flow Profiles

    BD Anti-Kappa APC and PE reagents used in flow cytometry testing may exhibit uncharacteristic flow profiles, potentially affecting test accuracy. Worldwide distribution to 249 units across US states and Taiwan.

    Product
    BD Anti-Kappa APC (Cat. No. 341098) is an analyte specific reagent for the Anti-Kappa antibody, which specifically recognizes the kappa light chains of human immunoglobulins. Anti-Kappa is used for in vitro identification of cells expressing the kappa light chains using flow cyto
    Category
    Distribution
    29 states
  • HighFDA (Devices)··2022-06-08

    BD Anti-Kappa PE Flow Cytometry Reagent May Show Inaccurate Results

    Becton Dickinson is recalling 199 units of BD Anti-Kappa PE flow cytometry reagent because samples may exhibit uncharacteristic flow profiles that could affect test accuracy.

    Product
    BD Anti-Kappa PE (Cat. No. 346587) is an analyte specific reagent for the Anti-Kappa antibody, which specifically recognizes the kappa light chains of human immunoglobulins. Anti-Kappa is used for in vitro identification of cells expressing the kappa light chains using flow cytom
    Category
    Distribution
    29 states