Colorimeter, Photometer, Spectrophotometer For Clinical Use
FDA adverse event reports and recall history for colorimeter, photometer, spectrophotometer for clinical use (product code JJQ), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 355
- Deaths
- 1
- Injuries
- 8
- Malfunctions
- 301
Reports per year
Source: FDA adverse event reports by year received, 2011–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Recent recalls
- 2025-10-23Open, ClassifiedSoftware design
BD Veritor Connect Software, labeled as the following: 1. Veritor (NUC), Catalog Number: 444881. Transfers in vitro diagnostic results data on the BD Veritor Plus Analyzer to BD Synapsys.
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.
- 2022-11-18Open, ClassifiedNonconforming Material/Component
MicroScan autoSCAN-4 Instrument, Catalog Number B1018-280
Due to MicroScan autoSCAN-4 Instruments being manufactured with an incorrect diffuser plate.
- 2016-08-25TerminatedNonconforming Material/Component
Infinite F50 instrument. The INFINITE F50 instrument is a 96-well absorbance reader for the measurement of light absorbance (optical density) of liquid media. The instrument is intended to be used primarily in in-vitro diagnostic analysis of samples from the human body to obtain information on physiological and pathological states. For applications in human clinical diagnostic uses, only the Magellan Tracker software is intended for the use with the instrument. Software and instrument have been validated for measurement and for the evaluation of qualitative and quantitative Enzyme-linked Immunosorbent Assays (ELISA) according to the scheduled diagnostic parameters and instrument specifications; they are therefore for professional use in in-vitro diagnostics
The batteries have the potential to overheating, melt or char.
- 2016-08-25TerminatedNonconforming Material/Component
SUNRISE instrument. The INFINITE F50 instrument is a 96-well absorbance reader for the measurement of light absorbance (optical density) of liquid media. The instrument is intended to be used primarily in in-vitro diagnostic analysis of samples from the human body to obtain information on physiological and pathological states. For applications in human clinical diagnostic uses, only the Magellan Tracker software is intended for the use with the instrument. Software and instrument have been validated for measurement and for the evaluation of qualitative and quantitative Enzyme-linked Immunosorbent Assays (ELISA) according to the scheduled diagnostic parameters and instrument specifications; they are therefore for professional use in in-vitro diagnostics
The batteries have the potential to overheating, melt or char.
- 2016-08-25TerminatedNonconforming Material/Component
Tecan Infinite 200. The SUNRISE instrument is a 96-well absorbance reader for the measurement of light absorbance (optical density) of liquid media. The instrument is intended to be used primarily in in-vitro diagnostic analysis of samples from the human body to obtain information on physiological and pathological states. For applications in human clinical diagnostic uses, only the Magellan Tracker software is intended for the use with the instrument. Software and instrument have been validated for measurement and for the evaluation of qualitative and quantitative Enzyme-linked Immunosorbent Assays (ELISA) according to the scheduled diagnostic parameters and instrument specifications; they are therefore for professional use in in-vitro diagnostics.
The batteries have the potential to overheating, melt or char.
- 2016-08-25TerminatedNonconforming Material/Component
Infinite 200 PRO The Tecan Infinite 200 PRO is a multifunctional microplate reader with injector option. The Infinite 200 PRO provides high performance for the vast majority of todays microplate applications and research and is robotic compatible. The Infinite 200 PRO has been designed as a general purpose laboratory instrument for professional use, supporting common 6 to 384-well microplates conforming to the ANSI/SBS standards.
The batteries have the potential to overheating, melt or char.
- 2016-08-25TerminatedNonconforming Material/Component
Tecan Infinite M1000 The Tecan Infinite M1000 is a multifunctional monochromator based microplate reader that provides high performance for the vast majority of todays microplate applications and research. Besides offering absorbance and fluorescence intensity measurements, the Infinite M1000 allows the measurement of fluorescence polarization and luminescence. The Infinite M1000 is also robotic compatible and offers a built-in stacker option as well as an external injector module. The Infinite M1000 is intended as a general purpose laboratory instrument for professional use, supporting common microplates conforming to the ANSI/SBS standards
The batteries have the potential to overheating, melt or char.
- 2016-08-25TerminatedNonconforming Material/Component
Tecan Infinite M1000 PRO The Tecan Infinite M1000 PRO is a multifunctional monochromator-based microplate reader that provides high performance for the vast majority of todays microplate applications and research. In addition to offering absorbance and fluorescence intensity measurements, the Infinite M1000 PRO can also perform fluorescence polarization and luminescence measurements (including luminescence scans) as well as Amplified Luminescent Proximity Homogeneous Assays (AlphaScreen and AlphaLISA). The Infinite M1000 PRO is also robotic compatible and offers a built-in stacker option as well as an external injector module. The Infinite M1000 PRO is intended as a general purpose laboratory instrument for professional use, supporting common microplates conforming to the ANSI/SBS standards.
The batteries have the potential to overheating, melt or char.
- 2009-09-18TerminatedSoftware design
BioTek Gen5CL Microplate Data Collection and Analysis Software. Intended for clinical lab use with ELx800 and ELx808 microplate readers, offers preprogrammed clinical diagnostic assays within a PC-based application.
Software design allowed false negatives to be read when wells are dark.
- 2009-03-30TerminatedDevice Design
Diasorin LIAISON (R) Chemiluminescence Analyzer Model # 15970. Colorimeter, Photometer, Spectrophotometer for clinical use.
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.
Monitor colorimeter, photometer, spectrophotometer for clinical use automatically
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