# FDA recall Z-1084-2026

> **Diagnostica Stago, Inc.** · Class II · device recall initiated 2025-12-15.

## Product

Asserachrom HPIA.   Model/Catalog Number: 00615.    The Asserachrom HPIA kit is intended for the qualitative detection in plasma or serum of the anti-heparin-platelet factor 4 (PF4) antibodies generated during the type II heparin-induced thrombocytopenia (HIT type II) by ELISA.

## Reason for recall

Potential for defect for Asserachrom HPIA lot 271288, which can affect every well in the impacted strip and produce negative results.

## Distribution

Worldwide - US Nationwide distribution in the states of AL, CA, FL, GA, HI, IA, MA, MI, NJ, NV, NY, OH, TN, WI and the countries of Belgium, Canada, Denmark, Algeria, Spain, Finland, France, Great Britain, Italy, Lebanon, Saudi Arabia, Uganda.

## Key facts

- **Recall number:** Z-1084-2026
- **Recalling firm:** Diagnostica Stago, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-12-15
- **Report date:** 2026-01-21

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Parsippany, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1084-2026

## Citation

> AI Analytics. FDA recall Z-1084-2026. Retrieved 2026-07-11 from https://api.ai-analytics.org/recall/Z-1084-2026. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*