Device product
Pacific Hemostasis Thromboplastin-D, 10 ml. Used in performing one-stage prothrombin time test and factor assays.
Z-1503-2025
Product summary
- Event
- Event 96488
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 1,699 units
- Official record key
device-enforcement:Z-1503-2025
Official wording
Reason: The incorrect value of the International Sensitivity Index (ISI) is printed on the outer box label.
Code information: Catalog No. 100357; UDI: 00845275000798665150270131100357; Lot No. 665150; Exp. Date 01/31/2027.
Distribution pattern: US Distribution to: PA and OUS Foreign country of: United Arab Emirates.
Derived failure modes
-
Unknown
The incorrect value of the International Sensitivity Index (ISI) is printed on the outer box label.