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
Reported: April 26, 2023 Initiated: March 9, 2023 #Z-1396-2023
Product Description
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
Reason for Recall
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
Details
- Recalling Firm
- Ortho-Clinical Diagnostics, Inc.
- Units Affected
- 256 units
- Distribution
- US Nationwide distribution in the states of AL, AZ, CA, GA, NY.
- Location
- Raritan, NJ
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Ortho-Clinical Diagnostics, Inc.. Units affected: 256 units.
Why was this product 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
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 26, 2023. Severity: Moderate. Recall number: Z-1396-2023.
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