Ortho-Clinical Diagnostics, Inc. Recall 88875
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
Ortho-Clinical Diagnostics, Inc. Recall 88875 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0247-2022 |
| Event ID | 88875 |
| Event 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 |
| Product Type | Devices |
| Distribution | 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. |
| Quantity | 191 units |
| Recall Reason | 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. |
| Device Classification | 20211124 |
| Device Code Info | Lot 1690 UDI 10758750001200 |
| Center Classification Date | 20211117 |
| Recall Initiation Date | 20211015 |
| Recalling Firm | Ortho-Clinical Diagnostics, Inc. |
| Initial Notification | Letter |
| Similar To |