Device product
Anti-SARS-CoV-2 IgG Quantitative Reagent Pack- Intended for use on VITROS¿ ECi/ECiQ/3600 Immunodiagnostic Systems and VITROS¿ 5600/XT 7600 Integrated Systems. Product Code: 6199960
Z-1367-2022
Product summary
- Event
- Event 90408
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 20858
- Official record key
device-enforcement:Z-1367-2022
Official wording
Reason: On-Analyzer Stability (OAS) time, supported for 6 weeks; not 8 weeks as is currently stated in the Instructions For Use (IFU).
Code information: UDI-DI :10758750034413. All expired, in-date and future released lots
Distribution pattern: Worldwide distribution - US Nationwide and the countries of Colombia, India, Singapore.
Derived failure modes
-
Unknown
On-Analyzer Stability (OAS) time, supported for 6 weeks; not 8 weeks as is currently stated in the Instructions For Use (IFU).