Device product
MicroVue C1-Inhibitor Plus EIA for measuring the amount of functional C1-lnhibitor protein in human plasma or serum, Catalog Number A037, Containing Coated Strips, REF: 4634, with an ID number of 2200 or above
Z-1308-2023
Product summary
- Event
- Event 91772
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 771 units
- Official record key
device-enforcement:Z-1308-2023
Official wording
Reason: Kits with affected microtiter plates have the potential to produce low OD values, causing the run to fail, per the Validation requirements of the Package Insert.
Code information: UDI: 30014613335580; Lot Number: 213783
Distribution pattern: not yet available
Derived failure modes
-
Unknown
Kits with affected microtiter plates have the potential to produce low OD values, causing the run to fail, per the Validation requirements of the Package Insert.