Brand Name: Alinity hq Analyzer Product Name: Alinity hq Analyzer

Class II, the middle of FDA’s three classes.

Codes to check against yours

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…

FDA’s list runs to 29,999 characters. The first part is shown; the rest is on FDA’s record.

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.

The states and territories these words name

• Alabama
• California
• Colorado
• Florida
• Indiana
• Minnesota
• North Carolina
• New York
• Oklahoma

What FDA means by nationwide

The words say it went outside the United States too.

Ongoing, in FDA’s file.

• The firm began the recall on Sep 18, 2025.
• FDA classified it on Nov 12, 2025.
• FDA’s Enforcement Report published it on Nov 19, 2025.

• Abbott Laboratories, of Santa Clara, CA.
• Who began it, in FDA’s words: Voluntary: Firm initiated.

• Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
• Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
• How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
• Whether anyone was hurt or fell ill: the report doesn’t say.
• How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
• FDA’s list of codes runs to 29,999 characters; the first part is shown here, and the rest is on FDA’s record.
• A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.

• U.S. Food and Drug Administration, Device recall enforcement reports.

  Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.

• This record in openFDA