Device 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).

Z-2994-2018

July 24, 2018

Class II

Product summary

Firm: Diagnostica Stago, Inc.
Event: Event 80826
Status: Terminated
Classification: Class II
Quantity: 5 kits
Official record key: device-enforcement:Z-2994-2018

Official wording

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

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

Distribution pattern: Nationwide

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

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