Device product
VITROS Immunodiagnostic Products Troponin I ES Reagent Pack
Z-2357-2023
Product summary
- Event
- Event 92662
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 4,013 units
- Official record key
device-enforcement:Z-2357-2023
Official wording
Reason: Reagent packs could potentially contain incorrect wells, which will generate incorrect, and potentially false negative, results.
Code information: Product Code: 6802301; UDI-DI: 10758750002504; Lot No.: 4800; Expiration Date: 10-Jun-2023.
Distribution pattern: Worldwide distribution - US Nationwide and the country of Canada.
Derived failure modes
-
Unknown
Reagent packs could potentially contain incorrect wells, which will generate incorrect, and potentially false negative, results.