VITEK® MS CHCARecalls & reported problems
Biomerieux SA · The VITEK MS-CHCA matrix is used with the VITEK® MS System to enable identification of microorganisms. The matrix absorbs energy from the VITEK MS laser and transfers it to the microorganisms · Class 2
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-0815-2023 · 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 FABiomerieux 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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.