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Becton Dickinson & Co.

186 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
BD GasPak EZ CO2 Pouch System. Catalog Number: 260684. for microbiologic use recall (Z-1982-2026)Becton Dickinson & Co.2026-04-29
BD GasPak EZ Campy Pouch System. Catalog Number: 260685. for microbiologic use recall (Z-1983-2026)Becton Dickinson & Co.2026-04-29
BD Kiestra" Isolate Suspension Cuvette Array; Catalog No.: 246100; recall (Z-0484-2026)Becton Dickinson & Co.2025-11-07
BD EpiCenter Microbiology Data Management System, labeled as the following: 1. Computer Sy recall (Z-0235-2026)Becton Dickinson & Co.2025-10-23
BD BACTEC Blood Culture System, labeled as the following: 1. BD BACTEC FX, Instrument Top, recall (Z-0236-2026)Becton Dickinson & Co.2025-10-23
BD BACTEC Blood Culture System, labeled as the following: 1. BACTEC 9120 System, Catalog N recall (Z-0237-2026)Becton Dickinson & Co.2025-10-23
BD MAX System, for in vitro diagnostic (IVD) use, labeled as the following: 1. BD MAX Syst recall (Z-0238-2026)Becton Dickinson & Co.2025-10-23
BD Phoenix M50 Instrument, labeled as the following: 1. BD Phoenix M50 Automated Microbiol recall (Z-0239-2026)Becton Dickinson & Co.2025-10-23
BD Veritor Connect Software, labeled as the following: 1. Veritor (NUC), Catalog Number: 4 recall (Z-0240-2026)Becton Dickinson & Co.2025-10-23
BD COR System Software. Model Number: 444829. recall (Z-2162-2025)Becton Dickinson & Co.2025-07-23
BD BACTEC MGIT 960 PZA Kit. IVD qualitative procedure for susceptibility testing of Mycoba recall (Z-2023-2025)Becton Dickinson & Co.2025-06-25
BD BBL TB Stain Kit K, Catalog (REF): 212522 recall (Z-1296-2025)Becton Dickinson & Co.2025-03-06
BD PCR Cartridges used with MAX System. Model Number: 437519 recall (Z-1004-2025)Becton Dickinson & Co.2025-01-21
BD BBL Sensi Disc Ampicillin 2 g (AM-2) - In-Vitro BD BBL Sensi Disc Ampicillin 2 g (AM-2) recall (Z-0621-2025)Becton Dickinson & Co.2024-12-05
BD EpiCenter Single User Software Version or Model: 441007 Catalog Number: 441007 recall (Z-0584-2025)Becton Dickinson & Co.2024-12-03
BD EpiCenter Data Management System Version or Model: 440887 Catalog Number: 440887 recall (Z-0585-2025)Becton Dickinson & Co.2024-12-03
BD EpiCenter Data Management System, Multi User Software Version or Model: 440981 Catalog recall (Z-0586-2025)Becton Dickinson & Co.2024-12-03
BD COR PX Instrument Version or Model: 443988 Catalog Number: 443988 recall (Z-0587-2025)Becton Dickinson & Co.2024-12-03
BD COR MX Instrument Version or Model: 443989 Catalog Number: 443989 recall (Z-0588-2025)Becton Dickinson & Co.2024-12-03
BD COR GX Instrument Version or Model: 443990 Catalog Number: 443990 recall (Z-0589-2025)Becton Dickinson & Co.2024-12-03
BD MAX System, BD MAX Instrument Version or Model: 441916 Catalog Number: 441916 recall (Z-0590-2025)Becton Dickinson & Co.2024-12-03
BD Synapsys Informatics Solution (Laboratory Solution) Version or Model: 444150 Catalog Nu recall (Z-0591-2025)Becton Dickinson & Co.2024-12-03
BD Phoenix M50 Automated Microbiology System Version or Model: 443624 Catalog Number: 4436 recall (Z-0592-2025)Becton Dickinson & Co.2024-12-03
BD BACTEC FX, Instrument Top, Packaged Version or Model: 441385 Catalog Number: 441385 recall (Z-0593-2025)Becton Dickinson & Co.2024-12-03
BD BACTEC FX40 Instrument Version or Model: 442296 Catalog Number: 442296 recall (Z-0594-2025)Becton Dickinson & Co.2024-12-03
BACTEC 9120 System Version or Model: 445570 Catalog Number: 445570 recall (Z-0595-2025)Becton Dickinson & Co.2024-12-03
BACTEC 9240 System Version or Model: 445475 Catalog Number: 445475 recall (Z-0596-2025)Becton Dickinson & Co.2024-12-03
BD Synapsys Informatics Solution with software versions: 4.20, 4.30, 5.10, 5.20 and 5.30- recall (Z-0026-2025)Becton Dickinson & Co.2024-10-08
BD Phoenix M50 instrument -Intended for the rapid identification (ID) and antimicrobial su recall (Z-3246-2024)Becton Dickinson & Co.2024-09-24
BD Phoenix 100-Intended for the rapid identification (ID) and antimicrobial susceptibility recall (Z-3247-2024)Becton Dickinson & Co.2024-09-24
BD BACTEC MGIT 960 PZA Kit)- IVD qualitative procedure for susceptibility testing of Mycob recall (Z-2686-2024)Becton Dickinson & Co.2024-08-16
BD Kiestra Urine Culture Application Powered by BD Synapsys Informatics Solution; Catalog recall (Z-2585-2024)Becton Dickinson & Co.2024-08-14
BD SARS-CoV-2 Reagents for BD MAX" Systems. RT-PCR test to detect SARS-CoV-2 in nasal, nas recall (Z-2023-2024)Becton Dickinson & Co.2024-06-05
BD Phoenix NMIC-306 Panel is a self-inoculating (when used with a BD Phoenix Automated Mic recall (Z-1398-2024)Becton Dickinson & Co.2024-03-29
BD Phoenix Yeast ID Panel is a self-inoculating (when used with a BD Phoenix Automated Mic recall (Z-1399-2024)Becton Dickinson & Co.2024-03-29
Sensi Disc Amoxicillin with Clavulanic Acid 20/10 g, Catalog No. 231628 and 231629. These recall (Z-1011-2024)Becton Dickinson & Co.2024-02-08
BD BBL Sensi Disc Ampicillin - 10 g, Catalog No. 230705 and 231264; 2 g, Catalog No. 23126 recall (Z-1012-2024)Becton Dickinson & Co.2024-02-08
BD BBL Sensi Disc Ampicillin with Sulbactam 10/10 g, Catalog Number 231660. Used for semi- recall (Z-1013-2024)Becton Dickinson & Co.2024-02-08
BD BBL Sensi Disc Augmentin - 3g, Catalog Number 291270used for semi-quantitative in vitro recall (Z-1014-2024)Becton Dickinson & Co.2024-02-08
BD BBL Sensi Disc Azithromycin -15 g, Catalog Number 231682used for semi-quantitative in v recall (Z-1015-2024)Becton Dickinson & Co.2024-02-08
BD BBL Sensi Disc Aztreonam - 30 ug, used for semi-quantitative in vitro susceptibility te recall (Z-1016-2024)Becton Dickinson & Co.2024-02-08
BD BBL Sensi Disc Cefaclor - 30 ug, used for semi-quantitative in vitro susceptibility tes recall (Z-1017-2024)Becton Dickinson & Co.2024-02-08
BD BBL Sensi Disc Cefepime - 30 ug, used for semi-quantitative in vitro susceptibility tes recall (Z-1018-2024)Becton Dickinson & Co.2024-02-08
BD BBL Sensi Disc Cefixime - 5 ug, used for semi-quantitative in vitro susceptibility test recall (Z-1019-2024)Becton Dickinson & Co.2024-02-08
BD BBL Sensi Disc Cefotaxime - 30 ug, used for semi-quantitative in vitro susceptibility t recall (Z-1020-2024)Becton Dickinson & Co.2024-02-08
BD BBL Sensi Disc Cefpodoxime - 10 ug, used for semi-quantitative in vitro susceptibility recall (Z-1021-2024)Becton Dickinson & Co.2024-02-08
BD BBL Sensi Disc Ceftaroline - 30 ug, used for semi-quantitative in vitro susceptibility recall (Z-1022-2024)Becton Dickinson & Co.2024-02-08
BD BBL Sensi Disc Ceftazidime- 30 ug, used for semi-quantitative in vitro susceptibility t recall (Z-1023-2024)Becton Dickinson & Co.2024-02-08
BD BBL Sensi Disc Ceftriaxone- 30 ug, used for semi-quantitative in vitro susceptibility t recall (Z-1024-2024)Becton Dickinson & Co.2024-02-08
BD BBL Sensi Disc Cefuroxime- 30 ug, used for semi-quantitative in vitro susceptibility te recall (Z-1025-2024)Becton Dickinson & Co.2024-02-08
BD BBL Sensi Disc Chloramphenicol- 30 ug, used for semi-quantitative in vitro susceptibili recall (Z-1026-2024)Becton Dickinson & Co.2024-02-08
BD BBL Sensi Disc Ciprofloxacin- 5 ug, used for semi-quantitative in vitro susceptibility recall (Z-1027-2024)Becton Dickinson & Co.2024-02-08
BD BBL Sensi Disc Clarithromycin- 15 ug, used for semi-quantitative in vitro susceptibilit recall (Z-1028-2024)Becton Dickinson & Co.2024-02-08
BD BBL Sensi Disc Doripenem- 15 ug, used for semi-quantitative in vitro susceptibility tes recall (Z-1029-2024)Becton Dickinson & Co.2024-02-08
BD BBL Sensi Disc Ertapenem- 10 ug, used for semi-quantitative in vitro susceptibility tes recall (Z-1030-2024)Becton Dickinson & Co.2024-02-08
BD BBL Sensi Disc Imipenem- 10 ug, used for semi-quantitative in vitro susceptibility test recall (Z-1031-2024)Becton Dickinson & Co.2024-02-08
BD BBL Sensi Disc Levofloxacin- 5 ug, used for semi-quantitative in vitro susceptibility t recall (Z-1032-2024)Becton Dickinson & Co.2024-02-08
BD BBL Sensi Disc Meropenem- 10 ug, used for semi-quantitative in vitro susceptibility tes recall (Z-1033-2024)Becton Dickinson & Co.2024-02-08
BD BBL Sensi Disc Minocycline - 30 ug, used for semi-quantitative in vitro susceptibility recall (Z-1034-2024)Becton Dickinson & Co.2024-02-08
BD BBL Sensi Disc Moxifloxacin- 5 ug, used for semi-quantitative in vitro susceptibility t recall (Z-1035-2024)Becton Dickinson & Co.2024-02-08
BD BBL Sensi Disc Ofloxacin- 5 ug, used for semi-quantitative in vitro susceptibility test recall (Z-1036-2024)Becton Dickinson & Co.2024-02-08
BD BBL Sensi Disc Piperacillin/Tazobactam- 100/10 ug, used for semi-quantitative in vitro recall (Z-1037-2024)Becton Dickinson & Co.2024-02-08
BD BBL Sensi Disc Rifampin- 5 ug, used for semi-quantitative in vitro susceptibility testi recall (Z-1038-2024)Becton Dickinson & Co.2024-02-08
BD BBL Sensi Disc Sulfamethoxazole with Trimethoprim 23.75/1.25 ug, used for semi-quantita recall (Z-1039-2024)Becton Dickinson & Co.2024-02-08
BD BBL Sensi Disc Tetracycline 30 ug,used for semi-quantitative in vitro susceptibility te recall (Z-1040-2024)Becton Dickinson & Co.2024-02-08
BD BACTEC Plus Aerobic/F Culture Vials, Catalog Number 442023 recall (Z-0110-2024)Becton Dickinson & Co.2023-10-12
BD Synapsys Informatics Solution, Catalog Number 444150 recall (Z-2099-2023)Becton Dickinson & Co.2023-07-06
BD Veritor System for Rapid Detection of SARS-CoV-2 & Flu A+B, 30 Single Use Test Devices- recall (Z-1682-2023)Becton Dickinson & Co.2023-06-02
BD Kiestra InoqulA+ with BD Kiestra" InoqulA+" and BeA Software version 5.1 and 5.1.1 as p recall (Z-1415-2023)Becton Dickinson & Co.2023-04-20
BBL Chocolate II Agar- IVD for the isolation and cultivation of Neisseria species. Catalog recall (Z-0473-2023)Becton Dickinson & Co.2022-12-09
BD Phoenix PMIC/ID-107: The Phoenix PMIC/ID panel is used for the rapid identification and recall (Z-0232-2023)Becton Dickinson & Co.2022-11-14
BD Veritor Plus Analyzer - intended to provide rapid test results in near-patient settings recall (Z-0630-2022)Becton Dickinson & Co.2022-02-09
BD BBL Trypticase Soy Agar with 5% Sheep Blood, Catalog No. 221261, (non-selective, non-di recall (Z-0528-2019)Becton Dickinson & Co.2018-11-30
BD AffirM VPIII Microbial Identification Test recall (Z-1394-2017)Becton Dickinson & Co.2017-02-27
EpiCenter Plus Microbiology Data Management System software version 6.20A, when used in co recall (Z-1414-2017)Becton Dickinson & Co.2017-02-27
Trypticase TM Soy Agar with 5% Sheep Blood (TSA IITM) // MacConkey II Agar Cat. Number 221 recall (Z-1559-2016)Becton Dickinson & Co.2016-04-22
Vancomycin Screen Agar recall (Z-0473-2016)Becton Dickinson & Co.2015-12-23
Enterococcus Screen Agar QUAD Plate recall (Z-0474-2016)Becton Dickinson & Co.2015-12-23
BD Viper LT System, catalog number 442839 when used in conjunction with the BD ProbeTec Ch recall (Z-1816-2015)Becton Dickinson & Co.2015-06-18
BBL Port A Cul tubes, catalog number 221606. Patient sample collection tubes. BBL Port A C recall (Z-1746-2015)Becton Dickinson & Co.2015-06-10
BBL Port A Cul tubes with Swabs Sterile Pack, catalog number 221607. For patient sample co recall (Z-1747-2015)Becton Dickinson & Co.2015-06-10
TrypticaseTM Soy Agar with 5% Sheep Blood (TSA IITM) // MacConkey II Agar Trypticase Soy A recall (Z-0974-2015)Becton Dickinson & Co.2015-01-14
CDC Anaerobe 5% Sheep Blood Agar CDC Anaerobe 5% Sheep Blood Agar is an enriched, nonselec recall (Z-0975-2015)Becton Dickinson & Co.2015-01-14
Columbia Agar with 5% Sheep Blood Columbia Agar with 5% Sheep Blood is a general purpose c recall (Z-0976-2015)Becton Dickinson & Co.2015-01-14
BD BBL Vancomycin Screen Agar Catalog number 222204 Vancomycin Screen Agar is used to test recall (Z-2628-2014)Becton Dickinson & Co.2014-09-12
The BD MAX MRSA Assay, catalogue #442953. An automated qualitative in vitro diagnostic tes recall (Z-2618-2014)Becton Dickinson & Co.2014-09-10
BBL CrystaLEAD Enteric/Nonfermentor (E/NF) Identification (ID) System, catalog number 2450 recall (Z-2041-2014)Becton Dickinson & Co.2014-07-11
BD BACTEC FX- Top Unit instrument, catalog number 441385, and Bottom Unit instrument, cata recall (Z-0869-2014)Becton Dickinson & Co.2014-01-30
BD BACTEC FX 40 instrument, catalog number 442296, manufactured by BD Diagnostic Systems, recall (Z-0870-2014)Becton Dickinson & Co.2014-01-30
BD GeneOhm Cdiff Assay, Part #441401, containing Lysis Kit sample buffer tubes, 200 tests/ recall (Z-0790-2014)Becton Dickinson & Co.2014-01-17
BBL (tm) MGIT (tm) Mycobacteria Growth Indicator Tube, part # 245122, packaged in 100 ct c recall (Z-0028-2014)Becton Dickinson & Co.2013-10-19
PrepStain AG. For use in the screening and detection of cervical cancer. recall (Z-2110-2013)Becton Dickinson & Co.2013-08-28
PrepStain Tecan US-I. For use in the screening and detection of cervical cancer. recall (Z-2111-2013)Becton Dickinson & Co.2013-08-28
PrepStain Tecan US-II. For use in the screening and detection of cervical cancer. recall (Z-2112-2013)Becton Dickinson & Co.2013-08-28
BD Affirm VPIII Microbial Identification Tests, packaged in kits, 120 test\kit, Catalog # recall (Z-1812-2013)Becton Dickinson & Co.2013-07-26
BD BBL Vancomycin Screen Agar, carton of 10 plates, catalog # 222204, labeled in part ***B recall (Z-1798-2013)Becton Dickinson & Co.2013-07-24
BD BBL Schaedler K-V Agar with 5% Sheep Blood, carton of 20 plates, catalog # 221555, labe recall (Z-1799-2013)Becton Dickinson & Co.2013-07-24
BD BBL CDC Anaerobe 5% Sheep Blood Agar with Kanamycin and Vancomycin (KV), packaged in ca recall (Z-1800-2013)Becton Dickinson & Co.2013-07-24
BD BBL Anaerobe CNA Agar with 5% Sheep Blood // Anaerobe Laked Sheep Blood KV Agar, packag recall (Z-1801-2013)Becton Dickinson & Co.2013-07-24
BD BBL BBE // CDC Anaerobe Laked Sheep Blood Agar with KV, packaged in cartons of 100 plat recall (Z-1802-2013)Becton Dickinson & Co.2013-07-24
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