Diagnostica Stago, Inc. recalls Diagnostica Stago STA N¿oplastine¿ CI Plus, 10 ml vial. In-Vitro Diagnostic for determination of the prothrombin time (…

Recall date

July 24, 2018

Source

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

Recall number

Z-2993-2018

FDA classification

Class II

Brand / firm

Diagnostica Stago, Inc.

Sold / distributed

Nationwide

Why it was recalled

QC values outside of the assigned ranges (prolonged Prothrombin time / decreased PT %)

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

What was recalled

Diagnostica Stago STA N¿oplastine¿ CI Plus, 10 ml vial. In-Vitro Diagnostic for determination of the prothrombin time (PT) in plasma. (REF 00667) The STA¿ - N¿oplastine¿ CI Plus kits provide reagents for the determination of the prothrombin time (PT) in plasma with STA-R¿, STA Compact¿ and STA Satellite¿. (In the USA this procedure has been assigned to the moderate complexity category per CLIA 1988 - CDC Analyte Code 4922; CDC Test System Codes 4677 and 4875).