Reported Jul 20, 2022 · Ongoing
Anti-SARS-CoV-2 IgG Quantitative Reagent Pack- Intended for use on VITROS¿ ECi/ECiQ/3600 Immunodiagnostic Systems and…
Ortho-Clinical Diagnostics, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Ortho-Clinical Diagnostics, Inc. · 100 Indigo Creek Dr · Rochester, NY · 14626-5101
Is this the product you have?
- 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 Code6199960
- Lot codes and dates
- UDI-DI10758750034413. All expired, in-date and future released lots
- Amount recalled
- 20858
Where it was sold
- Nationwide
Why it was recalled
On-Analyzer Stability (OAS) time, supported for 6 weeks; not 8 weeks as is currently stated in the Instructions For Use (IFU).
This product could cause temporary or reversible health problems — stop using it.
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