Z-1502-2025 Class II Ongoing
FDA device recall Z-1502-2025 was initiated by Fisher Diagnostics on March 6, 2025 and is designated Class II. Reason for recall: The incorrect value of the International Sensitivity Index (ISI) is printed on the outer box label. The recall status is ongoing. Affected quantity: 4,387 units.
Recall Details
- Product Type
- Devices
- Report Date
- April 9, 2025
- Initiation Date
- March 6, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 4,387 units
Product Description
Pacific Hemostasis Thromboplastin-D, 4 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.
Distribution Pattern
US Distribution to: PA and OUS Foreign country of: United Arab Emirates.
Code Information
Catalog No. 100356; UDI: 00845275000542719170261130100356; Lot No. 719170; Exp. Date 11/30/26.