FDAFDA · Food and drugs·Recall number Z-1069-2018
STA - Neoplastine¿ Cl Plus ¿ (ref. 00606) Product Usage: Manual or automated determination of the prothrombin time (PT).
Published March 21, 2018 · Recall initiated: October 25, 2017
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
Confirmed defect of homogeneity where some reagent vials will give prolonged Prothrombin Time (decreased PT%).
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Diagnostica Stago, Inc.
- Distributor
- Nationally
- Lot
- Lot: 250041RX (Exp: 2018-02) Lot: 250077 (Exp: 2018-02) Lot: 250246RU (Exp: 2018-03) Lot: 251492 (Exp: 2018-09) Lot: 251308 (Exp: 2018-10) Lot: 251626 (Exp: 20 19-01) Lot: 251730 (Exp: 2019-02) Lot: 251772 (Exp: 2019-02)
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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