The Recall Desk

Manufacturer

Becton, Dickinson and Company, BD Biosciences

35 recalls in our database name Becton, Dickinson and Company, BD Biosciences as the manufacturing or recalling firm.

What the numbers show

Total
35
Critical
0
Severe
1
Most recent
2024-07-24

Of the 35 recalls from Becton, Dickinson and Company, BD Biosciences we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 1 (3%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

26–35 of 35

  • LowFDA (Devices)·Z-2378-2016·2016-08-17

    BD Tritest CD3/CD4/CD45 Reagent Recalled for Incorrect Labeling

    Becton, Dickinson and Company is recalling 14,089 vials of BD Tritest CD3 FITC/CD4 PE/CD45 PerCP because the label incorrectly states the product contains gelatin.

    Product
    BD Tritest CD3 FITC/CD4 PE/CD45 PerCP (IVD); Catalog number 340383. Label states: Contains CD3 FITC/CD4 PE/CD45 per CP with Gelatin and 0.1% sodium azide. Hematology: BD Tritest CD3 fluorescein isothiocyanate (FITC)/CD4 phycoerythrin (PE)/CD45 peridinin chlorophyll protei
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2252-2016·2016-07-27

    BD Trucount Tubes Recalled for Potential Sealing Defects

    Becton, Dickinson and Company is recalling one lot of BD Trucount Absolute Counting Tubes because they may not be sealed properly, which can degrade product performance.

    Product
    BD Trucount Tubes: Catalog number: 340334 Hematology: BD Trucount tubes are used for determining absolute counts of leucocytes in blood.
    Category
    Medical Device
    Distribution
    17 states
  • ModerateFDA (Devices)·Z-1570-2016·2016-05-04

    BD Trucount Absolute Counting Tubes Recalled for Lot Mixing

    Becton, Dickinson and Company is recalling one lot of BD Trucount tubes because some pouches may contain tubes from a different lot, presenting a low risk to patient safety.

    Product
    BD Trucount Absolute Counting Tubes: Model number: 340334 IVD; BD Trucount tubes are 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 flo
    Category
    Medical Device
    Distribution
    10 states
  • LowFDA (Devices)·Z-1390-2016·2016-04-20

    BD Retic-Count Reagent System Recalled for Incorrect Storage Labeling

    Becton, Dickinson and Company is recalling one lot of BD Retic-Count Reticulocyte Reagent System because the carton label listed incorrect storage conditions.

    Product
    BD-Retic-Count Reticulocyte Reagent System; Hematology: Used for in vitro diagnostics
    Category
    Medical Device
    Distribution
    10 states
  • LowFDA (Devices)·Z-0851-2016·2016-03-02

    BD FMC7 FITC Recalled for Incorrect Expiration Date Labeling

    Becton, Dickinson and Company is recalling 78 units of BD FMC7 FITC reagent because the vial labels display an incorrect expiration date.

    Product
    BD FMC7 FITC: Model 430918. FMC7 is intended for in vitro diagnostic use in the identification of cells expressing FMC7 antigen. Product Usage: Analyte Specific Reagent. FMC7 is intended for in vitro diagnostic use in the identification of cells expressing FMC7 antigen.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0628-2016·2016-01-20

    BD Biosciences Recalls FMC7 FITC Reagent Due to Functional Degradation

    Becton, Dickinson and Company is recalling FMC7 FITC reagents because functional degradation reduces the percent positive from 100% to approximately 87%.

    Product
    FMC7 FITC, Catalog No. 340918 Analyte Specific Reagent.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0334-2016·2015-12-02

    BD CD64 APC-R700 Reagent Recalled Due to CD4 Antibody Contamination

    Becton, Dickinson and Company is recalling three lots of CD64 APC-R700 reagent because they are contaminated with CD4 antibody, which may cause unexpected staining patterns.

    Product
    BD CD64 APC-R700; Analyte Specific Reagent; Model 657701; Lot No. 4344945, 5037611 and 5063945. Hematology - used as analyte specific reagent - contamination leads to possibility of unexpected staining pattern.
    Category
    Medical Device
    Distribution
    9 states
  • LowFDA (Devices)·Z-0171-2016·2015-11-04

    BD CD3 FITC Recalled for Spanish Labeling Error

    Becton, Dickinson and Company is recalling two lots of BD CD3 (SK7) FITC in vitro diagnostic reagents due to an error in the Spanish small text on the label.

    Product
    BD CD3 (SK7) FITC; IVD; Catalog # 349201 and 340542 Hematology: The CD3 antibody reacts with the epsilon chain of the CD3 antigen/T-cell antigen receptor (TCR) complex. In vitro diagnostic.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2817-2015·2015-09-30

    BD Biosciences Recalls CD4 FITC Reagent Due to Spanish Labeling Error

    Becton, Dickinson and Company is recalling 128 units of CD4 (SK3), FITC reagent because the Spanish text on the label incorrectly identifies the product as CD8 FITC.

    Product
    CD4 (SK3), FITC; Contains CD4 FITC with gelatin and 0.1% sodium Azide. Catalog number 340133 in vitro diagnostic used in Hematology: The SK3 monoclonal antibody reacts with human CD4, a 59-kDa cell surface receptor expressed by a majority of thymocytes, a subpopulation of ma
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2453-2015·2015-09-02

    BD CD56 PE Cy 7 Reagent Recalled for Unexpected Staining Patterns

    Becton, Dickinson and Company is recalling three lots of CD56 PE Cy 7 reagent because they contain a low amount of HLA-DR PE antibody, which could result in an unexpected staining pattern.

    Product
    BD CD56 PE Cy 7: NCAM16.2 ASR Analyte Specific Reagent, Catalog number 335809 Hematology: The CD 56 antigen promotes homophilic adhesion in neurons and may be involved in homophilic adhesion of NK cells.
    Category
    Medical Device
    Distribution
    0 states