Recall Z-0247-2022 ยท JJX Single (Specified) Analyte Controls (Assayed And Unassayed)
Ortho-Clinical Diagnostics, Inc.
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
| Date | Oct 15, 2021 |
| Status | Terminated |
| 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. |
| Root cause | Under Investigation by firm |
| Action | On October 15, 2021, the firm issued "Important Product Correction Notification" letters to affected customers. Customers were informed that up to 8 booklets in the affected lot contained the range of means information for VITROS Immunodiagnostic Products Anti-HBc Controls instead of the control values for VITROS Anti-HBc IgM. Customers were provided with a copy of the correct Controls Values booklet. Customers were asked to do the following: - Complete and return the included Confirmation of Receipt - Response Required customer response form by email to: ra-ocdus-confirmad@orthoclinicaldia |
| Quantity | 191 units |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K032993 | VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC IGM CONTROLS Ortho-Clinical Diagnostics, Inc., Oct 31, 2003 |