Colorimeter, Photometer, Spectrophotometer For Clinical Use
Clinical Chemistry · 21 CFR 862.2300
Recent MDR events
355 adverse event reports on file
- BD VERITOR¿ PLUS ANALYZERJun 15, 2026MalfunctionBecton, Dickinson & Co. (sparks)1119779-2026-00947
- BD VERITOR¿ PLUS ANALYZERMay 1, 2026MalfunctionBecton, Dickinson & Co. (sparks)1119779-2026-00740
- BD VERITOR¿ PLUS ANALYZERMay 1, 2026MalfunctionBecton, Dickinson & Co. (sparks)1119779-2026-00741
- BD VERITOR¿ PLUS ANALYZERMay 1, 2026MalfunctionBecton, Dickinson & Co. (sparks)1119779-2026-00742
- BD VERITOR¿ PLUS ANALYZERMar 20, 2026MalfunctionBecton, Dickinson & Co. (sparks)1119779-2026-00441
- BD VERITOR¿ PLUS ANALYZERMar 20, 2026MalfunctionBecton, Dickinson & Co. (sparks)1119779-2026-00442
- EREADER+ DRUG SCREENING INSTRUMENTMar 10, 2026MalfunctionAmeditech, Inc.2032598-2026-00001
- BD VERITOR¿ PLUS ANALYZERFeb 9, 2026MalfunctionBecton, Dickinson & Co. (sparks)1119779-2026-00120
- BD VERITOR¿ PLUS ANALYZERFeb 9, 2026MalfunctionBecton, Dickinson & Co. (sparks)1119779-2026-00118
- BD VERITOR¿ PLUS ANALYZERFeb 9, 2026MalfunctionBecton, Dickinson & Co. (sparks)1119779-2026-00121
Event type breakdown
Recalls
17 recall events for this product code
- Becton Dickinson & Co.Open, ClassifiedOct 23, 2025
BD Veritor Connect Software, labeled as the following:
Product service credentials used by some BD technical support teams to access certain BD products were accessed by an unauthorized actor. Until these product service credentials are updated, there is a risk of unauthorized access that may impact the confidentiality, integrity and/or availability of the relevant products and associated data.
Z-0240-2026 · View FDA record ↗ - Beckman Coulter, Inc.Open, ClassifiedNov 18, 2022
MicroScan autoSCAN-4 Instrument, Catalog Number B1018-280
Due to MicroScan autoSCAN-4 Instruments being manufactured with an incorrect diffuser plate.
Z-0269-2023 · View FDA record ↗ - Tecan US, Inc.TerminatedAug 25, 2016
Infinite F50 instrument.
The batteries have the potential to overheating, melt or char.
Z-2660-2016 · View FDA record ↗ - Tecan US, Inc.TerminatedAug 25, 2016
SUNRISE instrument.
The batteries have the potential to overheating, melt or char.
Z-2661-2016 · View FDA record ↗ - Tecan US, Inc.TerminatedAug 25, 2016
Tecan Infinite 200.
The batteries have the potential to overheating, melt or char.
Z-2662-2016 · View FDA record ↗ - Tecan US, Inc.TerminatedAug 25, 2016
Infinite 200 PRO
The batteries have the potential to overheating, melt or char.
Z-2663-2016 · View FDA record ↗ - Tecan US, Inc.TerminatedAug 25, 2016
Tecan Infinite M1000
The batteries have the potential to overheating, melt or char.
Z-2664-2016 · View FDA record ↗ - Tecan US, Inc.TerminatedAug 25, 2016
Tecan Infinite M1000 PRO
The batteries have the potential to overheating, melt or char.
Z-2665-2016 · View FDA record ↗ - BioTek Instruments, Inc.TerminatedSep 18, 2009
BioTek Gen5CL Microplate Data Collection and Analysis Software.
Software design allowed false negatives to be read when wells are dark.
Z-2223-2009 · View FDA record ↗ - Diasorin Inc.TerminatedMar 30, 2009
Diasorin LIAISON (R) Chemiluminescence Analyzer Model # 15970.
DiaSorin determined that there was a potential for a short to occur in a a residual starter pump electrical cable in the LIAISON (R) Analyzer.
Z-1042-2009 · View FDA record ↗
Registered firms
102 firms currently registered for this product code
Horiba Instruments Incorporated
Canton, MI, US
Smile Line Sa
St-Imier Bern, CH
Scitek Global Co.,ltd
Jinan Shandong, CN
Infitek Co., Ltd.
Shanghai, CN
Hemagen Diagnostics, Inc.
Baltimore, MD, US
Advanced Instruments, Llc
WESTBROOK, ME, US
Zhejiang Orient Gene Biotech
Huzhou Zhejiang, CN
Elhoda Trade And Supplies
Badr industerial city Al Qahirah, EG
Atom Medical Corporation
Sakura-ku, Saitama-shi, JP
Innokas Medical Estonia Ou
Tallinn Harjumaa, EE
Iul Sa
Barcelona, ES
Diasorin Inc.
Stillwater, MN, US
Siemens Healthcare Diagnostics Inc.
NEWARK, DE, US
Creation Technologies Ltd
Burnaby British Columbia, CA
Siemens Healthcare Diagnostics Products Gmbh
MARBURG Hesse, DE
Becton, Dickinson & Co.
SPARKS, MD, US
Sanmina, Huntsville, Al
HUNTSVILLE, AL, US
Dirui Industrial Co., Ltd.
CHANGCHUN Jilin, CN
Codonics, Inc.
Middleburg Heights, OH, US
Teco Diagnostics
ANAHEIM, CA, US
Labpeak Co.,ltd
Jinan Shandong, CN
Vigilant Biosciences Inc.
Lakeway, TX, US
Guangzhou Konmison Technology Co., Ltd.
Guangzhou Guangdong, CN
Shanghai Kehua Laboratory System Co., Ltd.
Shanghai, CN
510(k) clearances
258 clearances for this product code
- Otsuka Pharmaceutical Co., Ltd.Dec 21, 2001
K013371 · UBIT-IR300 INFRARED SPECTROMETRY SYSTEM
- Digene Corp.Feb 6, 1998
K980120 · DIGENE DML 2000 MICROPLATE LUMINOMETER
- Sfri, Inc.Feb 4, 1998
K973938 · ALPHA 4 LS AUTOMATED MICROTITERPLATE PROCESSOR AND READER
- Awareness Technology, Inc.Jan 28, 1998
K974762 · STAT TRACKS
- Columbia Bioscience, Inc.Nov 5, 1996
K962113 · ANTHOS PHACTS VERSION MICROPLATE READER
- Columbia Bioscience, Inc.Aug 2, 1996
K961183 · CBI 7520 READER
- Igen, Inc.Jul 31, 1996
K962166 · ORIGEN ANALYZER
- Anthos Labtec, Inc.Dec 4, 1995
K955077 · ANTHOS 2010 READER