VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Control - Product Usage: For 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)
This recall has been terminated (originally issued September 30, 2020).
- Company
- Ortho Clinical Diagnostics Inc
- Recall Initiated
- September 30, 2020
- Terminated
- December 7, 2023
- Recall Number
- Z-0451-2021
- Quantity
- 691 units (OUS)
- Firm Location
- Raritan, NJ
- Official Source
- View on FDA website ↗
Reason for Recall
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
Distribution
Worldwide distribution - US Nationwide distribution and the countries of Australia, Brazil, Chile, China, Colombia, India, Japan, Singapore 609917, United Kingdom, Italy.
Lot / Code Info
Lot Number/ Exp. Date: 0110 25-NOV-20
Root Cause
Nonconforming Material/Component
Action Taken
Ortho Clinical Diagnostics issued Urgent Product Correction Notice on 30 Sept 2020 via(CL2020-246) of the issue and instructed as follows: If they are unable to calibrate (now or in the future) using an affected lot of VITROS Anti-SARS-CoV-2 IgG Calibrator Ortho will replace their remaining inventory as indicated on their Confirmation of Receipt form. NOTE: If they have a successful calibration, and quality control results are acceptable, the laboratory may continue using the affected lots for qualitative detection of IgG antibodies to SARS-CoV-2. If they are using the affected product to qualify units as high titer for CPT, consult with your medical director to determine if they should continue testing while waiting for their replacement product. Ortho will replace or credit their remaining inventory as indicated on their Confirmation of Receipt form. Post this notification by each system that processes the affected lots of VITROS Anti-SARS-CoV-2 IgG Calibrator or Control. Complete the enclosed Confirmation of Receipt form no later than October 9, 2020. Indicate the quantity of their remaining inventory to be replaced or credited. Please forward this notification if the product was distributed outside of their facility