# FDA recall Z-0489-2026

> **Abbott Laboratories** · Class II · device recall initiated 2025-09-18.

## Product

Brand Name: Alinity hq Analyzer  Product Name: Alinity hq Analyzer  Model/Catalog Number: 09P68-01  Software Version: 5.0 to 5.10.1 for OUS, 5.7 and 5.10.1 in the US  Product Description: Alinity hq Analyzer  Component: No

## Reason for recall

Software issue for hq analyzer results in system not visibly applying appropriate flagging to results when saturation is present which may result in incorrect results.

## Distribution

Worldwide distribution: US (nationwide) to states of: AL, CA, CO, FL, IN, MN, NC, NY, OK and OUS (foreign) to countries of: ALBANIA, ARGENTINA,	AUSTRALIA, BANGLADESH, BELGIUM, BOSNIA AND HERZEGOVINA, BRAZIL, BULGARIA, CANADA, CAYMAN ISLANDS, CHILE, COLOMBIA, CROATIA, CZECH REPUBLIC, DENMARK, EGYPT,	FRANCE, GERMANY, GREECE, HONG KONG, HUNGARY, INDIA, INDONESIA,	ITALY, JAMAICA, JAPAN, JORDAN, KUWAIT,	LEBANON, LITHUANIA, MALAYSIA, MALDIVES, MEXICO, NETHERLANDS,	NORWAY, OMAN, PAKISTAN, PANAMA, PHILIPPINES, POLAND, PORTUGAL, QATAR, ROMANIA, SAUDI ARABIA, SERBIA, SLOVENIA, SOUTH AFRICA, SOUTH KOREA, SPAIN, SWITZERLAND, THAILAND, TRINIDAD & TOBAGO, TURKEY, UAE,UNITED KINGDOM,	URUGUAY,  and VIETNAM.

## Key facts

- **Recall number:** Z-0489-2026
- **Recalling firm:** Abbott Laboratories
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-09-18
- **Report date:** 2025-11-19

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Santa Clara, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0489-2026

## Citation

> AI Analytics. FDA recall Z-0489-2026. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/Z-0489-2026. Source: US FDA. Licensed CC0.

---

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