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Diagnostica Stago, Inc. recalls Diagnostica Stago STA N¿oplastine¿ CI Plus, 10 ml vial. In-Vitro Diagnostic for determination of the prothrombin time
Recalled September 19, 2018 · FDA recall Z-2993-2018 · Diagnostica Stago
Hazard
QC values outside of the assigned ranges (prolonged Prothrombin time / decreased PT %) · FDA Class II
Units
24043 kits
Sold at
Nationwide
Description
QC values outside of the assigned ranges (prolonged Prothrombin time / decreased PT %)
Product
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).
Manufacturer(s)
Diagnostica Stago, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →