Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Anti-SARS-CoV-2 IgG Quantitative Reagent Pack- Intended for use on VITROS¿ Recalled by Ortho-Clinical Diagnostics, Inc. Due to On-Analyzer Stability (OAS) time, supported for 6 weeks;...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Ortho-Clinical Diagnostics, Inc. directly.
Affected Products
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
Quantity: 20858
Why Was This Recalled?
On-Analyzer Stability (OAS) time, supported for 6 weeks; not 8 weeks as is currently stated in the Instructions For Use (IFU).
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Ortho-Clinical Diagnostics, Inc.
Ortho-Clinical Diagnostics, Inc. has 62 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report