Z-2357-2023 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- August 16, 2023
- Initiation Date
- June 5, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 4,013 units
Product Description
VITROS Immunodiagnostic Products Troponin I ES Reagent Pack
Reason for Recall
Reagent packs could potentially contain incorrect wells, which will generate incorrect, and potentially false negative, results.
Distribution Pattern
Worldwide distribution - US Nationwide and the country of Canada.
Code Information
Product Code: 6802301; UDI-DI: 10758750002504; Lot No.: 4800; Expiration Date: 10-Jun-2023.