Clinical Diagnostic Systems recalls VITROS Immunodiagnostic Products TSH Reagent Pack

Recall date

January 11, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1322-2018

FDA classification

Class III

Brand / firm

Clinical Diagnostic Systems

Sold / distributed

Distributors were notified via letter. Lot 5430 was not distributed in the US. Lot 5178 was also affected by this issue, but this lot expired on 31-Mar-2017 so Ortho took no action on this lot.

Why it was recalled

VITROS TSH reagent lots have been found to generate higher than expected Calibrator level 2 signals on some customer systems. These Calibrator Level 2 responses cause a higher than expected frequency of customer generated calibration curves to fall outside of the calibration quality parameter measuring the gradient of the Customer Calibration Curve between Calibrator Level 2 and Calibrator Level 3.

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

VITROS Immunodiagnostic Products TSH Reagent Pack