Reported Nov 25, 2020 · Terminated
VITROS¿ Immunodiagnostic Products Anti-SARS-CoV-2 IgG Control - Product Usage: For use in monitoring the performance of…
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 · 1001 US Highway 202 · Raritan, NJ · 08869-1424
Is this the product you have?
- VITROS¿ Immunodiagnostic Products Anti-SARS-CoV-2
- IgG Control - Product UsageFor use in monitoring the performance of the VITROS Immunodiagnostic and Integrated Systems when used for the determination of IgG antibodies to SARS-CoV-2
- Product Code (Unique Identifier)6199921 (10758750033355)
- Lot codes and dates
- Lot Number/ Exp
- Date0110 25-NOV-20
- Amount recalled
- 691 units (OUS)
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
- Nationwide
Why it was recalled
Elevated sample results signal/cutoff (s/c) values when using eight (8) lots of VITROS immunodiagnostic Products Anti-SARS-CoV-2 IgG Calibrator and decreased signal in one (1) lot of VITROS¿ Immunodiagnostic Products Anti-SARS-CoV-2 IgG Control
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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