Z-0247-2022 Class III Terminated
FDA device recall Z-0247-2022 was initiated by Ortho-Clinical Diagnostics, Inc. on October 15, 2021 and is designated Class III. Reason for recall: Ortho Clinical Diagnostics confirmed a complaint that some VITROS Immunodiagnostic Products Anti-HBc IgM Controls Lot 1690 Controls Values booklet contained information for the incorrect product. Whil… The recall status is terminated (terminated December 18, 2023). Affected quantity: 191 units.
Recall Details
- Product Type
- Devices
- Report Date
- November 24, 2021
- Initiation Date
- October 15, 2021
- Termination Date
- December 18, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 191 units
Product Description
VITROS Immunodiagnostic Products Anti-HBc IgM Controls, Product Code 6801427 For use in monitoring the performance of the VITROS ECi/ECiQ/3600 Immunodiagnostic Systems and the VITROS 5600/XT 7600 Integrated Systems
Reason for Recall
Ortho Clinical Diagnostics confirmed a complaint that some VITROS Immunodiagnostic Products Anti-HBc IgM Controls Lot 1690 Controls Values booklet contained information for the incorrect product. While the accuracy of patient test results is not affected by this issue, there is a potential for delayed results due to the troubleshooting of Quality Control results.
Distribution Pattern
US (Domestic) distribution to states of: AZ, CA, CO, CT, FL, GA, LA, MA, MO, NJ, NY, OK, SC, SD, TX, UT, WA, WI, and WV. OUS (Foreign) distribution to Colombia.
Code Information
Lot 1690 UDI 10758750001200