Z-0450-2021 Class II Terminated
FDA device recall Z-0450-2021 was initiated by Ortho Clinical Diagnostics Inc on September 30, 2020 and is designated Class II. 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¿ Immunodia… The recall status is terminated (terminated December 7, 2023). Affected quantity: 651 units.
Recall Details
- Product Type
- Devices
- Report Date
- November 25, 2020
- Initiation Date
- September 30, 2020
- Termination Date
- December 7, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 651 units
Product Description
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)
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 Pattern
Worldwide distribution - US Nationwide distribution and the countries of Australia, Brazil, Chile, China, Colombia, India, Japan, Singapore 609917, United Kingdom, Italy.
Code Information
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