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Abbott Laboratories recalls Brand Name: Alinity hq Analyzer Product Name: Alinity hq Analyzer Model/Catalog Number: 09P68-01 Software Version: 5.
Recalled November 19, 2025 · FDA recall Z-0489-2026 · Abbott Laboratories
Hazard
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. · FDA Class II
Units
833
Sold at
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.
Description
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.
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
Manufacturer(s)
Abbott Laboratories
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →