Voluntary Recall of Cardiac Marker

A voluntary recall of four lots of the Troponin I reagent pack distributed to clinical laboratories by Ortho-Clinical Diagnostics, Inc. (Raritan, NJ, USA), has been announced by the company.

Recalled were reagent pack #1949882, lots 1110 and 1130 (distributed worldwide), and reagent pack #6801857, lots 2510 and 2530 (distributed in the United States). These Vitros immunodiagnostic products are used to aid doctors in the diagnosis of a heart attack.

Ortho-Clinical Diagnostics has received complaints of random occurrences of false-positives, which could lead to unnecessary medical procedures. A company investigation has determined that the occurrences were limited to an interaction between a component in the affected lots and specific patient plasma samples. All current and future lots are undergoing enhanced testing designed to screen for this potential interaction.

Ortho-Clinical Diagnostics has notified all customers with affected lot numbers, and has informed the U.S. Food and Drug Administration (FDA) of the action. Replacement products were provided. The company has instructed clinical laboratories to stop using the products, discard any remaining material, and to notify the healthcare provider who ordered the test. No injuries have been reported to date.




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