medical Class III Updated 2021-11-24

Ortho-Clinical Diagnostics, Inc. recalls VITROS Immunodiagnostic Products Anti-HBc IgM Controls, Prod

Recalled 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


Hazard / Issue

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.

Issued by

FDA

Affected States: AZ, CA, CO, CT, FL, GA, LA, MA, MO, NJ, NY, OK, SC, SD, TX, UT, WA, WI, WV
Lot/Code Info: Lot 1690 UDI 10758750001200
View official government recall

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