Device product
VIDAS SARS-COV-2 IgM, Ref 423833-01
Z-0438-2022
Product summary
- Firm
- bioMerieux, Inc.
- Event
- Event 88797
- Status
- Ongoing
- Classification
- Class II
- Quantity
- One lot
- Official record key
device-enforcement:Z-0438-2022
Official wording
Reason: bioMerieux has been receiving an increasing number of complaints linked to a VIDAS substrate error. It prevents the test from being run, therefore leads to potential delayed results as the user must run another test.
Code information: UDI 03573026620738, Lot #: 1008710950
Distribution pattern: US Nationwide distribution.
Derived failure modes
-
Unknown
bioMerieux has been receiving an increasing number of complaints linked to a VIDAS substrate error. It prevents the test from being run, therefore leads to potential delayed results as the user must run another test.