System, Mass Spectrometry, Maldi Tof, Microorganism Identification, Cultured Isolates
FDA adverse event reports and recall history for system, mass spectrometry, maldi tof, microorganism identification, cultured isolates (product code PEX), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 431
- Deaths
- 0
- Injuries
- 10
- Malfunctions
- 420
Reports per year
Source: FDA adverse event reports by year received, 2015–2021. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Recent recalls
- 2023-01-04Open, ClassifiedStorage
VITEK MS CLINICAL REAGENT VITEK MS-DS, CATALOG 410893
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
- 2023-01-04Open, ClassifiedStorage
VITEK MS CLINICAL REAGENT VITEK MS-CHCA, CATALOG 411071
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
- 2023-01-04Open, ClassifiedStorage
VITEK MS CLINICAL REAGENT VITEK MS-FA, CATALOG 411072
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
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