FDA-Device2023-04-26Class II
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 Code: 6199976
Ortho-Clinical Diagnostics, Inc.
Hazard
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
Sold states
US Nationwide distribution in the states of AL, AZ, CA, GA, NY.
Affected count
256 units
Manufactured in
1001 Us Highway 202, N/A, Raritan, NJ, United States
Products
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 Code: 6199976
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1396-2023Don't want to check this manually?
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