Reported Apr 26, 2023 · Ongoing
VITROS Immunodiagnostic Products Anti-SARSCoV- 2 Total N Antibody Calibrators programmed onto the Assay Data Disks…
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-SARSCoV- 2 Total N Antibody Calibrators programmed onto the Assay Data
- Disks (ADD) Data Release Versions (DRV)DRVs 6213 through 6218 supporting VITROS Calibrators
- Product Code6199976
- Lot codes and dates
- UDI10758750034581 Lot # /Expiration
- Date
0230 22-Feb-20230240 22-Mar-20230250 26-Apr-2023
- Amount recalled
- 256 units
Where it was sold
Why it was recalled
Incorrect Number of Calibrator Levels (2) Set for the VITROS Immunodiagnostics Products Anti-SARS-CoV-2 Total N Antibody Calibrators in Assay Data Disks (ADD), resulting in delayed patients results
This product could cause temporary or reversible health problems — stop using it.
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