Ortho-Clinical Diagnostics recalls 1) VITROS¿ Immunodiagnostic Products Total Beta-hCG II Reagent Pack (Unique Device Identifier No. 10758750002320, 20758…

Recall date

February 18, 2016

Source

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

Recall number

Z-1700-2016

FDA classification

Class II

Brand / firm

Ortho-Clinical Diagnostics

Sold / distributed

Nationwide Distribution.

Why it was recalled

When testing was conducted using certain lots, VITROS¿ Systems generated results within the measuring range for samples known to not contain measurable hCG. The system reported results up to approximately 7.40 mIU/mL (IU/L) for patient samples that should have been less than the measuring range of the assay (<2.39 mIU/mL (IU/L)).

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

1) VITROS¿ Immunodiagnostic Products Total Beta-hCG II Reagent Pack (Unique Device Identifier No. 10758750002320, 20758750002327) and the 2)VITROS¿ Immunodiagnostic Products Total Beta-hCG II Calibrators (Unique Device Identifier No. 10758750002337, 20758750002334); For quantitative measurement of human chorionic gonadotropin (hCG) and its beta subunit in human serum and plasma.