Recall archive / FDA device enforcement
Pacific Hemostasis Thromboplastin-D, 4 ml. Used in performing one-stage prothrombin time test and factor assays. — FDA record Z-1502-2025
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Mar 6, 2025. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- Pacific Hemostasis Thromboplastin-D, 4 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.
- Classification
- Class II
- Recalling firm
- Fisher Diagnostics
- Quantity
- 4,387 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-1502-2025
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | Catalog No. 100356; UDI: 00845275000542719170261130100356; Lot No. 719170; Exp. Date 11/30/26. |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
US Distribution to: PA and OUS Foreign country of: United Arab Emirates.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
Dates in the source
- Report date
- Apr 9, 2025
- Recall initiation date
- Mar 6, 2025
- Center classification date
- Mar 31, 2025
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.