Diagnostica Stago, Inc. recalls Diagnostica Stago STA N¿oplastine¿ CI, 10 ml vial. In-Vitro
Recalled Product
Diagnostica Stago STA N¿oplastine¿ CI, 10 ml vial. In-Vitro Diagnostic for determination of the prothrombin time (PT) in plasma. REF: 00666 The STA¿ - N¿oplastine¿ CI 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).
Hazard / Issue
QC values outside of the assigned ranges (prolonged Prothrombin time / decreased PT %)
Issued by
FDA
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