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Becton, Dickinson and Company, BD Biosciences FDA Recalls

8 recalls on file across devices, 0 of them Class I and 7 still open. Matched by name to BDX.

Newest first

Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.

Product
BD Multitest 6-Color TBNK CE-IVD, REF: 644611; BD Multitest 6-Color TBNK Kit with BD Trucount Tubes CE-IVD, REF: 337166Class IIMay 8, 2024Multitest with compromised raw material used to assess immun
CD11b APC: ASR, REF: 340936, and CE, REF: 333143Class IIOct 25, 2023In vitro diagnostics product that impacts the quality of cel
BD Multitest 6-Color TBNK with optional BD Trucount Tubes (Cat. No. 662995), for use with BD FACSLyric, BD FACSCanto II,Class IIOct 3, 2022Due to partial label detachment on tubes. This can cause tub
BD Trucount Tubes (Cat. No. 663028), used for determining absolute counts of leukocytes in blood. BD Trucount Tubes are Class IIOct 3, 2022Due to partial label detachment on tubes. This can cause tub
BD Trucount Tubes (Cat. No. 340334), used for determining absolute counts of leucocytes in blood. BD Trucount tubes are Class IIOct 3, 2022Due to partial label detachment on tubes. This can cause tub
BD Anti-Kappa APC (Cat. No. 341098) is an analyte specific reagent for the Anti-Kappa antibody, which specifically recogClass IIMar 25, 2022Anti-Kappa APC & Anti-Kappa PE analyte reagents may exhibit
BD Anti-Kappa PE (Cat. No. 346587) is an analyte specific reagent for the Anti-Kappa antibody, which specifically recognClass IIMar 25, 2022Anti-Kappa APC & Anti-Kappa PE analyte reagents may exhibit
BD" Mouse IgG2a Isotype Control APC X39 ASRClass IIJul 22, 2021Complaints have been received for performance issues related

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