# FDA recall Z-1502-2025

> **Fisher Diagnostics** · Class II · device recall initiated 2025-03-06.

## 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.

## Distribution

US Distribution to: PA and OUS Foreign country of: United Arab Emirates.

## Key facts

- **Recall number:** Z-1502-2025
- **Recalling firm:** Fisher Diagnostics
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-03-06
- **Report date:** 2025-04-09

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Middletown, VA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1502-2025

## Citation

> AI Analytics. FDA recall Z-1502-2025. Retrieved 2026-06-03 from https://api.ai-analytics.org/recall/Z-1502-2025. Source: US FDA. Licensed CC0.

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