Fisher Diagnostics Recall 96488
Description: Pacific Hemostasis Thromboplastin-D, 4 ml. Used in performing one-stage prothrombin time test and factor assays.
Fisher Diagnostics Recall 96488 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1502-2025 |
| Event ID | 96488 |
| Event Description | Pacific Hemostasis Thromboplastin-D, 4 ml. Used in performing one-stage prothrombin time test and factor assays. |
| Product Type | Devices |
| Distribution | US Distribution to: PA and OUS Foreign country of: United Arab Emirates. |
| Quantity | 4,387 units |
| Recall Reason | The incorrect value of the International Sensitivity Index (ISI) is printed on the outer box label. |
| Device Classification | 20250409 |
| Device Code Info | Catalog No. 100356; UDI: 00845275000542719170261130100356; Lot No. 719170; Exp. Date 11/30/26. |
| Center Classification Date | 20250331 |
| Recall Initiation Date | 20250306 |
| Recalling Firm | Fisher Diagnostics |
| Initial Notification | Letter |
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