Class II
Medical Device Recall: Pacific Hemostasis Thromboplastin-D, 10 ml. Used in performing one-stage prothrombin time test and factor assays.
Fisher Diagnostics · March 6, 2025
Reason for Recall
The incorrect value of the International Sensitivity Index (ISI) is printed on the outer box label.
Distribution
US Distribution to: PA and OUS Foreign country of: United Arab Emirates.
States Affected
PA
Quantity Affected
1,699 units
Source: FDA (openFDA Device Enforcement)
Recall number: Z-1503-2025
Status: ongoing
SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.