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 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.
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.
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0247-2022