Z-1396-2023 Class II Ongoing
FDA device recall Z-1396-2023 was initiated by Ortho-Clinical Diagnostics, Inc. on March 9, 2023 and is designated Class II. 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 The recall status is ongoing. Affected quantity: 256 units.
Recall Details
- Product Type
- Devices
- Report Date
- April 26, 2023
- Initiation Date
- March 9, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 256 units
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
Distribution Pattern
US Nationwide distribution in the states of AL, AZ, CA, GA, NY.
Code Information
UDI: 10758750034581 Lot # /Expiration Date: 0230 22-Feb-2023; 0240 22-Mar-2023; 0250 26-Apr-2023.