medical Class II Updated 2022-07-20

Ortho-Clinical Diagnostics, Inc. recalls Anti-SARS-CoV-2 IgG Quantitative Reagent Pack- Intended for

Recalled 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

Hazard / Issue

On-Analyzer Stability (OAS) time, supported for 6 weeks; not 8 weeks as is currently stated in the Instructions For Use (IFU).

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: UDI-DI :10758750034413. All expired, in-date and future released lots
View official government recall

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