FDAFDA · Food and drugs·Recall number Z-2994-2018
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).
Published September 19, 2018 · Recall initiated: July 24, 2018
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
QC values outside of the assigned ranges (prolonged Prothrombin time / decreased PT %)
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Diagnostica Stago, Inc.
- Distributor
- Nationwide
- Lot
- 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
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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