FDA Enforcement
Class II
Ongoing
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
Recall: Z-1367-2022
·
Reported July 20, 2022
Enforcement
- Recall Number
- Z-1367-2022
- Event ID
- 90408
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Ortho-Clinical Diagnostics, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- July 20, 2022
- Initiation Date
- May 26, 2022
- Classification Date
- July 12, 2022
- Address
- 100 Indigo Creek Dr, Rochester, NY, 14626-5101, United States
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
On-Analyzer Stability (OAS) time, supported for 6 weeks; not 8 weeks as is currently stated in the Instructions For Use (IFU).
Code Info
UDI-DI :10758750034413. All expired, in-date and future released lots
Distribution
Worldwide distribution - US Nationwide and the countries of Colombia, India, Singapore.
Quantity
20858