Abbott Laboratories recalls Brand Name: Alinity hq Analyzer Product Name: Alinity hq Analyzer

Recalling company

Abbott Laboratories

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

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.

Classification

Class II – may cause temporary or medically reversible health consequences

Recall date

Sep 18, 2025

Reported

Nov 19, 2025

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.

Status

Ongoing

Quantity

833

Lot / codes

SN UDI HQ00480 (01)380740138851(21)HQ00480 HQ01231 (01)380740138851(21)HQ01231 HQ01232 (01)380740138851(21)HQ01232 HQ01233 (01)380740138851(21)HQ01233 HQ01236 (01)380740138851(21)HQ01236 HQ01237 (01)380740138851(21)HQ01237 HQ01238 (01)380740138851(21)HQ01238 HQ01239 (01)380740138851(21)HQ01239 HQ01240 (01)380740138851(21)HQ01240 HQ01241 (01)380740138851(21)HQ01241 HQ01244 (01)380740138851(21)HQ01244 HQ01246 (01)380740138851(21)HQ01246 HQ01247 (01)380740138851(21)HQ01247 HQ01248 (01)380740138851(21)HQ01248 HQ01249 (01)380740138851(21)HQ01249 HQ01250 (01)380740138851(21)HQ01250 HQ01252 (01)380740138851(21)HQ01252 HQ01253 (01)380740138851(21)HQ01253 HQ01256 (01)380740138851(21)HQ01256 HQ01257 (01)380740138851(21)HQ01257 HQ01263 (01)380740138851(21)HQ01263 HQ01265 (01)380740138851(21)HQ01265 OUS: HQ00117 (01)380740138851(21)HQ00117 HQ00119 (01)380740138851(21)HQ00119 HQ00120 (01)380740138851(21)HQ00120 HQ00126 (01)380740138851(21)HQ00126 HQ00127 (01)380740138851(21)HQ00127 HQ00128 (01)380740138851(21)HQ00128 HQ00132 (01)380740138851(21)HQ00132 HQ00136 (01)380740138851(21)HQ00136 HQ00139 (01)380740138851(21)HQ00139 HQ00140 (01)380740138851(21)HQ00140 HQ00141 (01)380740138851(21)HQ00141 HQ00144 (01)380740138851(21)HQ00144 HQ00145 (01)380740138851(21)HQ00145 HQ00148 (01)380740138851(21)HQ00148 HQ00149 (01)380740138851(21)HQ00149 HQ00152 (01)380740138851(21)HQ00152 HQ00154 (01)380740138851(21)HQ00154 HQ00157 (01)380740138851(21)HQ00157 HQ00162 (01)380740138851(21)HQ00162 HQ00164 (01)

Company location

Santa Clara, CA

Recall type

Voluntary: Firm initiated

Recall number

Z-0489-2026

Agency

U.S. Food and Drug Administration (FDA)

View official FDA notice ↗ Search recall number Z-0489-2026 in the FDA Enforcement Report. Also see FDA recall press releases.