Home / Recalls / Diagnostica Stago, Inc. / Z-2994-2018

Z-2994-2018 Class II Terminated

Recalled by Diagnostica Stago, Inc. — Parsippany, NJ

Recall Details

Product Type
Devices
Report Date
September 19, 2018
Initiation Date
July 24, 2018
Termination Date
May 18, 2020
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
5 kits

Product Description

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).

Reason for Recall

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

Distribution Pattern

Nationwide

Code Information

Lot Number/Exp. Date/UDI 251426 2018-11-30 (01)03607450006667(11)161130(17)181130(10)251426(241)00666; 251763 2019-02-28 (01)03607450006667(11)170228(17)190228(10)251763(241)00666

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