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Open, Classified

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

FDA Recall Z-0489-2026 · Posted 2025-11-12

Recalling FirmAbbott Laboratories
Recall StatusOpen, Classified
Product CodeGKZ
Date Initiated2025-09-18
Product Quantity833

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.

Firm Action

On September 18, 2025, Abbott Laboratories issued an "Urgent Medical Device Recall" Notification. Abbott ask consignees to take the following actions: 1. If IG/%IG is above your laboratory established reference range (e.g. greater than 2%), review the results per your laboratory procedures. A manual smear review may need to be performed to confirm the results. 2. Complete and return the Customer Reply Form. 3. If you have forwarded the product listed above to other laboratories, please inform them of this Product Correction and provide to them a copy of this letter. 4. Please retain this letter for your laboratory records. If the problem persists, contact your Abbott representative or Abbott Technical Support (1-800-727-7846) for help to determine whether the inability to communicate is related to this issue.

Root Cause

Software design

Distribution Pattern

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K243283Alinity h-series SystemAbbott Laboratories · 2025-02-20K220031Alinity h-series SystemAbbott Laboratories · 2023-08-04

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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