VITEK® MS FARecalls & reported problems
Biomerieux SA · VITEK ® MS - FA is used to pretreat yeasts to facilitate their identification according to the MALDI - TOF method. It is used exclusively with the VITEK ® MS instrument. · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 0
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
No MAUDE adverse event reports in our data reference this device identifier directly.
1 FDA recall record name this device's identifier, 1 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Recalls naming this device
- Nov 9, 2022Open, Classified
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
Z-0816-2023 · Root cause: Storage · FDA record ↗
Other System, Mass Spectrometry, Maldi Tof, Microorganism Identification, Cultured Isolates devices
- VITEK® MS 410895Biomerieux SA · System, Mass Spectrometry, Maldi Tof, Microorganism Identification, Cultured Isolates615 reports
- VITEK® MS-DSBiomerieux SA · System, Mass Spectrometry, Maldi Tof, Microorganism Identification, Cultured Isolates1 recall1 report
- VITEK® MS CHCABiomerieux SA · System, Mass Spectrometry, Maldi Tof, Microorganism Identification, Cultured Isolates1 recall0 reports
- VITEK® MS MYCOBACTERIUM/NOCARDIA KITBiomerieux SA · System, Mass Spectrometry, Maldi Tof, Microorganism Identification, Cultured Isolates5 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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