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Ortho-Clinical Diagnostics, Inc. recalls Anti-SARS-CoV-2 IgG Quantitative Reagent Pack- Intended for use on VITROS¿ ECi/ECiQ/3600 Immunodiagnostic Systems and V
Recalled July 20, 2022 · FDA recall Z-1367-2022 · Ortho-Clinical Diagnostics
Hazard
On-Analyzer Stability (OAS) time, supported for 6 weeks; not 8 weeks as is currently stated in the Instructions For Use (IFU). · FDA Class II
Units
20858
Sold at
Worldwide distribution - US Nationwide and the countries of Colombia, India, Singapore.
Description
On-Analyzer Stability (OAS) time, supported for 6 weeks; not 8 weeks as is currently stated in the Instructions For Use (IFU).
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
Manufacturer(s)
Ortho-Clinical Diagnostics, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →