FDA Medical devices recall ·
Alinity hq Analyzer Product Name: Alinity hq Analyzer Model recall
- Recall number
- Z-0489-2026
- Date
- (initiated September 18, 2025)
- Company / brand
- Abbott Laboratories
4551 Great America Pkwy, Santa Clara, CA, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 833
- Hazard tags
- Software
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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
Why was it recalled?
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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
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)
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.
States: Alabama California Colorado Florida Indiana Minnesota North Carolina New York Oklahoma
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-0489-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.