Fisher Diagnostics: Device Recall
Recall #Z-1502-2025 · 03/06/2025
Class II: Risk
Recall Details
- Recall Number
- Z-1502-2025
- Classification
- Class II
- Product Type
- Device
- Recalling Firm
- Fisher Diagnostics
- Status
- Ongoing
- Date Initiated
- 03/06/2025
- Location
- Middletown, VA, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 4,387 units
Reason for Recall
The incorrect value of the International Sensitivity Index (ISI) is printed on the outer box label.
Product Description
Pacific Hemostasis Thromboplastin-D, 4 ml. Used in performing one-stage prothrombin time test and factor assays.
Distribution Pattern
US Distribution to: PA and OUS Foreign country of: United Arab Emirates.
Other Recalls by Fisher Diagnostics
- Class II: Risk 03/06/2025
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.