Pacific Hemostasis Thromboplastin-D — Class II medical device recall Z-1502-2025
Ongoing recall by Fisher Diagnostics, reported 2025-04-09. The incorrect value of the International Sensitivity Index (ISI) is printed on the outer box label.
| Recall number | Z-1502-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Fisher Diagnostics, Middletown, VA, United States |
| Recall initiated | 2025-03-06 |
| Classified | 2025-03-31 |
| Reported by FDA | 2025-04-09 |
| Countries outside the US | AE |
| Quantity | 4,387 units |
| Reason classes | labeling |
| Lot numbers | 719170 |
| Model numbers | 100356 |
| Expiration dates | 2026-11-30 |
Product
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1502-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.