Z-1367-2022 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- July 20, 2022
- Initiation Date
- May 26, 2022
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 20858
Product Description
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
Reason for Recall
On-Analyzer Stability (OAS) time, supported for 6 weeks; not 8 weeks as is currently stated in the Instructions For Use (IFU).
Distribution Pattern
Worldwide distribution - US Nationwide and the countries of Colombia, India, Singapore.
Code Information
UDI-DI :10758750034413. All expired, in-date and future released lots