Pacific Hemostasis Thromboplastin-D, 10 ml. Used in performing one-stage prothrombin time test and factor assays.
Reported: April 9, 2025 Initiated: March 6, 2025 #Z-1503-2025
Product Description
Pacific Hemostasis Thromboplastin-D, 10 ml. Used in performing one-stage prothrombin time test and factor assays.
Reason for Recall
The incorrect value of the International Sensitivity Index (ISI) is printed on the outer box label.
Details
- Recalling Firm
- Fisher Diagnostics
- Units Affected
- 1,699 units
- Distribution
- US Distribution to: PA and OUS Foreign country of: United Arab Emirates.
- Location
- Middletown, VA
Frequently Asked Questions
What product was recalled? ▼
Pacific Hemostasis Thromboplastin-D, 10 ml. Used in performing one-stage prothrombin time test and factor assays.. Recalled by Fisher Diagnostics. Units affected: 1,699 units.
Why was this product recalled? ▼
The incorrect value of the International Sensitivity Index (ISI) is printed on the outer box label.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 9, 2025. Severity: Moderate. Recall number: Z-1503-2025.
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