---
title: "Pacific Hemostasis Thromboplastin-D, 4 ml. Used in performing one-stage proth... — FDA record Z-1502-2025 | Is It on Recall"
description: "The incorrect value of the International Sensitivity Index (ISI) is printed on the outer box label."
url: https://isitonrecall.com/recall/fda-device-z-1502-2025-pacific-hemostasis-thromboplastin-d-4-ml-used-in-performing-one-stage-prothrombin-time-test-and-fact/
updated: 2026-10-01
site: "Is It on Recall"
language: en
---

[Recall archive](https://isitonrecall.com/archives/) / 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](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/).

## 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

[Open the official record](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1502-2025%22)

[What the recall classes mean](https://isitonrecall.com/guides/recall-classes/). 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.

- [Pennsylvania](https://isitonrecall.com/state/pennsylvania/)

## 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.

## What to do next

Read the official notice for the action that applies to your exact product.

[Read the current instructions](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1502-2025%22)

## Related records

[Medical devices records](https://isitonrecall.com/category/medical-devices/) [Fisher Diagnostics records](https://isitonrecall.com/brand/fisher-diagnostics/)