PlainRecalls
FDA Devices Moderate Class II Terminated

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).

Reported: September 19, 2018 Initiated: July 24, 2018 #Z-2993-2018

Product Description

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).

Reason for Recall

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

Details

Recalling Firm
Diagnostica Stago, Inc.
Units Affected
24043 kits
Distribution
Nationwide
Location
Parsippany, NJ

Frequently Asked Questions

What product 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).. Recalled by Diagnostica Stago, Inc.. Units affected: 24043 kits.
Why was this product recalled? ▼
QC values outside of the assigned ranges (prolonged Prothrombin time / decreased PT %)
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 19, 2018. Severity: Moderate. Recall number: Z-2993-2018.

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