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.

1–25 of 35

HighFDA (Devices)·Z-2351-2024·2024-07-24
BD Multitest 6-Color TBNK Reagent Contamination May Cause Erroneous Results
BD Multitest 6-Color TBNK flow cytometry reagent contains contaminated antibodies that may produce erroneous or delayed test results, potentially impacting clinical decisions.
Product
BD Multitest 6-Color TBNK CE-IVD, REF: 644611; BD Multitest 6-Color TBNK Kit with BD Trucount Tubes CE-IVD, REF: 337166; BD Multitest 6-Color TBNK, IVD, REF: 662967; BD Multitest 6-Color TBNK Kit with BD Trucount Tubes IVD, REF: 662995. BD Multitest" 6-Color TBNK reagent wit
Category
Medical Device
Distribution
34 states
HighFDA (Devices)·Z-0641-2024·2024-01-17
Medical diagnostic reagent recall: incorrect cell staining fluorescence
BD Biosciences is recalling CD11b APC diagnostic reagent vials that may produce dim fluorescence signals, potentially causing false negative results and misdiagnosis of blood cancers.
Product
CD11b APC: ASR, REF: 340936, and CE, REF: 333143
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0171-2023·2022-11-09
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
Medical Device
Distribution
43 states
HighFDA (Devices)·Z-0172-2023·2022-11-09
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
Medical Device
Distribution
43 states
ModerateFDA (Devices)·Z-0173-2023·2022-11-09
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
Medical Device
Distribution
43 states
HighFDA (Devices)·Z-1215-2022·2022-06-08
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
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1214-2022·2022-06-08
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
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2333-2021·2021-09-01
BD Mouse IgG2a Antibody Reagent Recalled for Manufacturing Contamination
This antibody reagent was recalled due to manufacturing contamination that may produce false positive staining results in laboratory tests. The affected lot was distributed worldwide.
Product
BD" Mouse IgG2a Isotype Control APC X39 ASR
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0562-2021·2020-12-16
BD Multi-Check CD4 Low Control Recalled for Inaccurate Flow Cytometry Results
Becton, Dickinson and Company is recalling 619 vials of BD Multi-Check CD4 Low Control due to unexpected cell populations that may cause inaccurate flow cytometry results.
Product
BD" Multi-Check CD4 Low Control 2.5 mL IVD - Product Usage: intended as a complete process control for immunophenotyping by flow cytometry.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2358-2020·2020-06-17
BD FACS Sample Prep Assistant III Recalled for Probe Wear Issues
Becton, Dickinson and Company is recalling 467 units of the BD FACS Sample Prep Assistant III because probes may wear prematurely, causing sample dispensing failures.
Product
BD FACS Sample Prep Assistant (SPA) III - Product Usage: Prep Assistant III is intended to prepare human whole blood for flow cytometric analysis on BD FACSCanto II and BD FACSCalibur flow cytometry systems. Pipetting blood, reagents, and lysing solution using the following previ
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2357-2020·2020-06-17
BD FACS Sample Prep Assistant II Upgrade Recalled for Probe Wear
Becton, Dickinson and Company is recalling 51 units of the BD FACS Sample Prep Assistant II Upgrade due to premature probe wear that may cause sample dispensing issues.
Product
BD FACS Sample Prep Assistant (SPA) II Upgrade - Product Usage: K050191: The BD FACSCanto system with BD FACSCanto clinical software when used with the BD FACS Sample Prep Assistant II /III is intended for use as an in vitro diagnostic device for identification and enumeration of
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2356-2020·2020-06-17
BD FACS Sample Prep Assistant II Recalled for Probe Wear Issues
Becton, Dickinson and Company is recalling 95 units of the BD FACS Sample Prep Assistant II because probes may wear prematurely, causing sample dispensing failures.
Product
BD FACS Sample Prep Assistant (SPA) II - Product Usage: K050191: The BD FACSCanto system with BD FACSCanto clinical software when used with the BD FACS Sample Prep Assistant II /III is intended for use as an in vitro diagnostic device for identification and enumeration of lymphoc
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1971-2020·2020-05-20
BD Biosciences Recalls CD45 Reagent Due to False Positive Reactions
Becton, Dickinson and Company is recalling 1,473 vials of Analyte specific reagent (CD45) because of false positive reactions. The product is used for in vitro diagnostic testing.
Product
Analyte specific reagent. REF/UDI: 641408/641408-4012-1-1 (US); 641417/641417-1157-1-01 (OUS); 641399/641399-4012-1-01 (US Research Use Only) - Product Usage: CD45 is intended for in vitro diagnostic use in the identification of cells expressing the CD45 antigen, using a BD FAC b
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0074-2020·2019-10-16
BD FACSLyric Flow Cytometers Recalled for Potential False High Counts
Becton, Dickinson and Company is recalling 22 BD FACSLyric Flow Cytometers because they may produce falsely high absolute counts when used with BD Trucount Tubes.
Product
BD FACSLyric Flow Cytometer, 3-Laser 12 Color Instrument, REF: 663029, when using BD Trucount Tubes
Category
Medical Device
Distribution
26 states
HighFDA (Devices)·Z-0071-2020·2019-10-16
BD FACSLyric Flow Cytometer Recall for Potential Inaccurate Cell Counts
BD Biosciences is recalling 36 BD FACSLyric Flow Cytometers because they may produce falsely high absolute cell counts when used with BD Trucount Tubes, potentially affecting clinical decisions.
Product
BD FACSLyric Flow Cytometer, 2-Laser 6 Color Instrument, REF: 651165, when using BD Trucount Tubes
Category
Medical Device
Distribution
26 states
HighFDA (Devices)·Z-0066-2020·2019-10-16
BD FACSLyric Flow Cytometer Recalled for Potential False High Counts
Becton, Dickinson and Company is recalling 12 BD FACSLyric Flow Cytometers because they may produce falsely high absolute counts when used with specific tubes, potentially affecting clinical decisions.
Product
BD FACSLyric Flow Cytometer, 2-Laser 4 Color Instrument, REF: 662875, when using BD Trucount Tubes
Category
Medical Device
Distribution
26 states
HighFDA (Devices)·Z-0068-2020·2019-10-16
BD FACSLyric Flow Cytometers Recalled for Potential False High Absolute Counts
Becton, Dickinson and Company is recalling eight BD FACSLyric Flow Cytometers because they may produce falsely high absolute counts when used with BD Trucount Tubes.
Product
BD FACSLyric Flow Cytometer, 3-Laser 8 Color Instrument, REF: 662877, when using BD Trucount Tubes
Category
Medical Device
Distribution
26 states
HighFDA (Devices)·Z-0069-2020·2019-10-16
BD FACSLyric Flow Cytometer Recall for Potential False High Counts
Becton, Dickinson and Company is recalling 78 BD FACSLyric Flow Cytometers because they may produce falsely high absolute counts when used with specific tubes, potentially affecting clinical decisions.
Product
BD FACSLyric Flow Cytometer, 3-Laser 10 Color Instrument, REF: 662878, and 66287808 when using BD Trucount Tubes
Category
Medical Device
Distribution
26 states
HighFDA (Devices)·Z-0070-2020·2019-10-16
BD FACSLyric Flow Cytometers Recalled for Potential False High Absolute Counts
Becton, Dickinson and Company is recalling 21 BD FACSLyric Flow Cytometers because they may produce falsely high absolute counts when used with specific tubes, potentially affecting clinical decisions.
Product
BD FACSLyric Flow Cytometer, 2-Laser 4 Color Instrument, REF: 651164, when using BD Trucount Tubes
Category
Medical Device
Distribution
26 states
HighFDA (Devices)·Z-0073-2020·2019-10-16
BD FACSLyric Flow Cytometer Recall for Potential False High Absolute Counts
Becton, Dickinson and Company is recalling 236 BD FACSLyric Flow Cytometers because they may produce falsely high absolute counts when used with BD Trucount Tubes.
Product
BD FACSLyric Flow Cytometer,3-Laser 10 Color Instrument, REF: 659180 and 65918001, when using BD Trucount Tubes
Category
Medical Device
Distribution
26 states
HighFDA (Devices)·Z-0067-2020·2019-10-16
BD FACSLyric Flow Cytometer Recalled for Potential False Absolute Counts
Becton, Dickinson and Company is recalling specific BD FACSLyric Flow Cytometers used with BD Trucount Tubes due to potential electronic errors that may result in falsely high absolute cell counts.
Product
BD FACSLyric Flow Cytometer, 2-Laser 6 Color Instrument, REF: 662876, when using BD Trucount Tubes
Category
Medical Device
Distribution
26 states
HighFDA (Devices)·Z-0072-2020·2019-10-16
BD FACSLyric Flow Cytometers Recalled for Potential False High Absolute Counts
Becton, Dickinson and Company is recalling 30 BD FACSLyric Flow Cytometers because they may produce falsely high absolute counts when used with BD Trucount Tubes, potentially affecting clinical decisions.
Product
BD FACSLyric Flow Cytometer, 3-Laser 8 Color Instrument, REF: 654587, when using BD Trucount Tubes
Category
Medical Device
Distribution
26 states
LowFDA (Devices)·Z-0792-2019·2019-02-13
BD FACSLyric Flow Cytometer Recalled Due to Unsupported Operating System Configuration
Becton, Dickinson and Company is recalling three BD FACSLyric flow cytometers because they were installed with an unsupported Windows 10 operating system configuration.
Product
BD FACSLyric 3L 10C with FACSuite Clinical Software v1.1.1, catalog number 662878 BD FACSLyric is a high-performance flow cytometer designed to support both routine clinical analysis and research for the identification, quantification, and characterization of cells in support
Category
Medical Device
Distribution
1 state
LowFDA (Devices)·Z-2598-2018·2018-08-08
BD FACS Universal Loader Recalled for Insufficient Locking Mechanism
Becton, Dickinson and Company is recalling 8 BD FACS Universal Loader devices because the solenoid plunger tip is too short to lock securely during use.
Product
BD FACS Universal Loader (Optional) to the BD FACSLyric Clinical System, Model 662879 (Universal Loader), Rx Only. The firm name on the label is Becton, Dickinson and Company, BD Biosciences, San Jose, CA. The Loader offers various settings to resuspend and mix samples. It c
Category
Medical Device
Distribution
6 states
ModerateFDA (Devices)·Z-0128-2017·2016-10-26
BD Biosciences Recalls Contaminated CD79b PE Antibody Reagent
Becton, Dickinson and Company is recalling 14 units of CD79b PE antibody reagent due to contamination with a FITC conjugate of unknown specificity.
Product
CD79b PE (ASR) , Catalog number 335816 ; Hematology: The CD79b antibody recognizes an epitope on the extracellular domain of a 3640 kilodalton (kDa) type I membrane glycoprotein. Immunoglobulin (Ig) antigen receptors are composed of a non-covalently associated complex of Ig
Category
Medical Device
Distribution
Distributed nationwide