Recall Z-0450-2021
Ortho Clinical Diagnostics Inc · initiated September 30, 2020
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
VITROS Immunodiagnostic Products-SARS-CoV-2 IgG Calibrator - Product Usage: In-Vitro Diagnostic (EUA) an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection. Emergency use of this test is limited to authorized laboratories-- Product Code (Unique Identifier): 6199920 (10758750033362)
Codes / lots: Lot Number/ Exp. Date: 0165 24-NOV-20 0180 19-NOV-20 0185 27-NOV-20 0190 21-NOV-20 0200 23-NOV-20 0205 27-NOV-20 0220 03-DEC-20 0230 03-DEC-20
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
FDA-determined 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
Details
- Recall number
- Z-0450-2021
- Initiated
- September 30, 2020
- Terminated
- December 7, 2023
- Product code
- QMN – Covid-19 Multi-Analyte Antigen Device
- Quantity
- 651 units
- Distribution
- Worldwide distribution - US Nationwide distribution and the countries of Australia, Brazil, Chile, China, Colombia, India, Japan, Singapore 609917, United Kingdom, Italy.
- Recalling firm
- Ortho Clinical Diagnostics Inc, Raritan, NJ
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0451-2021 Class II | VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Control - Product Usage: For use in…Elevated sample results signal/cutoff (s/c) values when using eight (8) lots of VITROS immunodiagnostic… | 09/30/2020Terminated |