FDA Device recall Z-1503-2025
Pacific Hemostasis Thromboplastin-D, 10 ml
- FDA Device
- Class II
- ongoing
- Published 2025-04-09
On 2025-04-09 the FDA classified a Class II recall of Pacific Hemostasis Thromboplastin-D, 10 ml by Fisher Diagnostics, citing the incorrect value of the International Sensitivity Index (ISI) is printed on the outer box label.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1503-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-03-06 |
| Published | 2025-04-09 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Fisher Diagnostics |
| Distribution | PA |
Product
Pacific Hemostasis Thromboplastin-D, 10 ml. Used in performing one-stage prothrombin time test and factor assays.
Reason
The incorrect value of the International Sensitivity Index (ISI) is printed on the outer box label.
Identifiers
| code_info | Catalog No. 100357; UDI: 00845275000798665150270131100357; Lot No. 665150; Exp. Date 01/31/2027. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1503-2025%22
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