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 System

Is my product affected?

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

• UPC 10758750001200

Check against the official notice below — it lists the full affected range.

What happened

Ortho Clinical Diagnostics recalled VITROS Immunodiagnostic Products Anti-HBc IgM Controls (Lot 1690, Product Code 6801427) because some units included a Controls Values booklet with information for an incorrect product. The company confirmed that this error does not affect the accuracy of patient test results. However, there is potential for delayed results while users troubleshoot Quality Control results. A total of 191 units were distributed domestically to Arizona, California, Colorado, Connecticut, Florida, Georgia, Louisiana, Massachusetts, Missouri, New Jersey, New York, Oklahoma, South Carolina, South Dakota, Texas, Utah, Washington, Wisconsin, and West Virginia, as well as to Colombia internationally.

The recall record does not specify a remedy or corrective action for affected consumers.

Written by software from the official notice below. Not reviewed by a lawyer.

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.

Details from the source

Reason for recall: 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. 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 Lot/code info: Lot 1690 UDI 10758750001200

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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