Home / Recalls / Medical Devices
Ortho-Clinical Diagnostics, Inc. recalls VITROS Immunodiagnostic Products Anti-HBc IgM Controls, Product Code 6801427 For use in monitoring the performance of t
Recalled November 24, 2021 · FDA recall Z-0247-2022 · Ortho-Clinical Diagnostics
Hazard
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. · FDA Class III
Units
191 units
Sold at
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.
Description
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.
Product
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
Manufacturer(s)
Ortho-Clinical Diagnostics, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →