Z-0451-2021 Class II Terminated
FDA device recall Z-0451-2021 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: 691 units (OUS).
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
- 691 units (OUS)
Product Description
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)
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: 0110 25-NOV-20