Becton, Dickinson and Company, BD Biosciences

Complete recall history across all FDA and CPSC categories — 35 total recalls

Becton, Dickinson and Company, BD Biosciences appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.

Device Recalls (35)

FDA medical device enforcement actions by Becton, Dickinson and Company, BD Biosciences

Date Product Reason Class
May 8, 2024 BD Multitest 6-Color TBNK CE-IVD, REF: 644611; BD Multitest 6-Color TBNK Kit... Multitest with compromised raw material used to assess immune system status m... Class II
Oct 25, 2023 CD11b APC: ASR, REF: 340936, and CE, REF: 333143 In vitro diagnostics product that impacts the quality of cell staining can ca... Class II
Oct 3, 2022 BD Trucount Tubes (Cat. No. 340334), used for determining absolute counts of ... Due to partial label detachment on tubes. This can cause tubes to become stuc... Class II
Oct 3, 2022 BD Trucount Tubes (Cat. No. 663028), used for determining absolute counts of ... Due to partial label detachment on tubes. This can cause tubes to become stuc... Class II
Oct 3, 2022 BD Multitest 6-Color TBNK with optional BD Trucount Tubes (Cat. No. 662995), ... Due to partial label detachment on tubes. This can cause tubes to become stuc... Class II
Mar 25, 2022 BD Anti-Kappa APC (Cat. No. 341098) is an analyte specific reagent for the An... Anti-Kappa APC & Anti-Kappa PE analyte reagents may exhibit uncharacteristic ... Class II
Mar 25, 2022 BD Anti-Kappa PE (Cat. No. 346587) is an analyte specific reagent for the Ant... Anti-Kappa APC & Anti-Kappa PE analyte reagents may exhibit uncharacteristic ... Class II
Jul 22, 2021 BD" Mouse IgG2a Isotype Control APC X39 ASR Complaints have been received for performance issues related to high backgrou... Class II
Oct 5, 2020 BD" Multi-Check CD4 Low Control 2.5 mL IVD - Product Usage: intended as a com... Recent product complaints showing an unexpected cell population exhibiting di... Class II
Mar 31, 2020 Analyte specific reagent. REF/UDI: 641408/641408-4012-1-1 (US); 641417/641417... False positive reaction on the reagent. Class II
Aug 19, 2019 BD FACSLyric Flow Cytometer, 3-Laser 8 Color Instrument, REF: 654587, when us... Flow cytometers, when used with specific tubes may experience excessive elect... Class II
Aug 19, 2019 BD FACSLyric Flow Cytometer, 2-Laser 6 Color Instrument, REF: 651165, when us... Flow cytometers, when used with specific tubes may experience excessive elect... Class II
Aug 19, 2019 BD FACSLyric Flow Cytometer,3-Laser 10 Color Instrument, REF: 659180 and 6591... Flow cytometers, when used with specific tubes may experience excessive elect... Class II
Aug 19, 2019 BD FACSLyric Flow Cytometer, 2-Laser 6 Color Instrument, REF: 662876, when us... Flow cytometers, when used with specific tubes may experience excessive elect... Class II
Aug 19, 2019 BD FACSLyric Flow Cytometer, 3-Laser 10 Color Instrument, REF: 662878, and 66... Flow cytometers, when used with specific tubes may experience excessive elect... Class II
Aug 19, 2019 BD FACSLyric Flow Cytometer, 2-Laser 4 Color Instrument, REF: 651164, when us... Flow cytometers, when used with specific tubes may experience excessive elect... Class II
Aug 19, 2019 BD FACSLyric Flow Cytometer, 3-Laser 8 Color Instrument, REF: 662877, when us... Flow cytometers, when used with specific tubes may experience excessive elect... Class II
Aug 19, 2019 BD FACSLyric Flow Cytometer, 2-Laser 4 Color Instrument, REF: 662875, when us... Flow cytometers, when used with specific tubes may experience excessive elect... Class II
Aug 19, 2019 BD FACSLyric Flow Cytometer, 3-Laser 12 Color Instrument, REF: 663029, when u... Flow cytometers, when used with specific tubes may experience excessive elect... Class II
Jul 8, 2019 BD FACS Sample Prep Assistant (SPA) II Upgrade - Product Usage: K050191: The ... The recalling firm confirmed that SPA II and III users may encounter probes ... Class II
Jul 8, 2019 BD FACS Sample Prep Assistant (SPA) III - Product Usage: Prep Assistant III i... The recalling firm confirmed that SPA II and III users may encounter probes ... Class II
Jul 8, 2019 BD FACS Sample Prep Assistant (SPA) II - Product Usage: K050191: The BD FACSC... The recalling firm confirmed that BD FACS Sample Prep Assistant (SPA) II and ... Class II
Jan 2, 2019 BD FACSLyric 3L 10C with FACSuite Clinical Software v1.1.1, catalog number 66... A customer site was identified to have three FACSLyric IVD systems with FACSu... Class III
May 16, 2018 BD FACS Universal Loader (Optional) to the BD FACSLyric Clinical System, Mode... The solenoid plunger tip length is too short resulting in insufficient engag... Class III
Sep 21, 2016 CD79b PE (ASR) , Catalog number 335816 ; Hematology: The CD79b antibody r... CD79b (SN8) PE is contaminated with a FITC conjugate of unknown antigenic spe... Class II
Jul 18, 2016 BD Tritest CD3 FITC/CD4 PE/CD45 PerCP (IVD); Catalog number 340383. Label s... Internal review found that some vials of CD3/CD4/CD45 state that the product ... Class III
Jun 24, 2016 BD Trucount Tubes: Catalog number: 340334 Hematology: BD Trucount tub... One lot of BD Trucount Absolute Counting Tubes (IVD) may not be sealed proper... Class II
Mar 31, 2016 BD Trucount Absolute Counting Tubes: Model number: 340334 IVD; BD Trucou... One lot of lot of BD Trucount tubes may contain tubes from another lot. There... Class II
Mar 18, 2016 BD-Retic-Count Reticulocyte Reagent System; Hematology: Used for in vitro ... The carton label for one lot of BD Retic-Count Reticulocyte Reagent System ha... Class III
Jan 25, 2016 BD FMC7 FITC: Model 430918. FMC7 is intended for in vitro diagnostic use in ... Becton, Dickinson and Company (BD) has determined that the FMC7 FITC (ASR) h... Class III
Dec 14, 2015 FMC7 FITC, Catalog No. 340918 Analyte Specific Reagent. Becton, Dickinson and Company (BD) has determined that the FMC7 FITC (ASR) is... Class III
Oct 30, 2015 BD CD64 APC-R700; Analyte Specific Reagent; Model 657701; Lot No. 4344945, 5... Three lots of CD64 (MD22) are contaminated with CD4 antibody. Class II
Sep 30, 2015 BD CD3 (SK7) FITC; IVD; Catalog # 349201 and 340542 Hematology: The CD3 a... Two lots of CD3 (SK7) FITC label contains an error in the Spanish Small text. Class III
Aug 27, 2015 CD4 (SK3), FITC; Contains CD4 FITC with gelatin and 0.1% sodium Azide. Cata... CD4 FITC label contains an error in the Spanish small text - it states CD8 FITC. Class III
Jul 17, 2015 BD CD56 PE Cy 7: NCAM16.2 ASR Analyte Specific Reagent, Catalog number 33580... Three lots of CD56 PE Cy 7, Catalog number 335809, contain a low amount of HL... Class II

Frequently Asked Questions

A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.

Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.

The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.

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