FDAFDA · Food and drugs·Recall number Z-1502-2025
Pacific Hemostasis Thromboplastin-D, 4 ml. Used in performing one-stage prothrombin time test and factor assays.
Published April 9, 2025 · Recall initiated: March 6, 2025
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
The incorrect value of the International Sensitivity Index (ISI) is printed on the outer box label.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Fisher Diagnostics
- Distributor
- US Distribution to: PA and OUS Foreign country of: United Arab Emirates.
- Lot
- Catalog No. 100356; UDI: 00845275000542719170261130100356; Lot No. 719170; Exp. Date 11/30/26.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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