Abbott recalls Alinity hq Analyzer (REF: 09P68-01) with software versions 5.7 (US) and 5.6 and below (OUS) due to potential false low red blood cell count results when running specific blood tests in sequence.
1)If Complete Blood Count with differential and reticulocyte(CBC+Diff+Retic) sample is run, then immediately following on same rack CBC+Diff sample is run, then falsely low red blood cell count may occur, generating falsely high Mean Cell Hemoglobin(MCH)/MCHC and falsely low hematocrit results. 2)Cell events may be incorrectly counted as basophil(BASO), resulting in increased BASO and %BASO counts
Take action
Contact the company
📍Recalling firmAbbott Laboratories4551 Great America Pkwy · Santa Clara, CA 95054-1208
✎ GovInfoNow plain-language explainer
Abbott is recalling certain Alinity hq Analyzers that may produce false low red blood cell count results when running a Complete Blood Count with differential and reticulocyte test followed by another CBC+Diff test. This could lead to inaccurate blood test results that might affect medical decisions. Read more at govinfonow.com/recall/54841-abbott-alinity-hq-analyzer-recall-false-low-red-blood-cell.
“Abbott Alinity hq Analyzer Recall: False Low Red Blood Cell Count Results.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/54841-abbott-alinity-hq-analyzer-recall-false-low-red-blood-cell. Based on FDA recall #Z-2681-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2681-2024%22&limit=1).
Abbott Laboratories recalled Alinity hq Analyzers on June 14, 2024, due to risks of falsely low red blood cell counts and incorrect basophil results, according to the FDA. Owners should contact Abbott for software updates.
How to tell if you have it
Brand: Abbott
Product: Alinity hq Analyzer
REF: 09P68-01
UDI-DI: 380740138851
Software Versions: 5.7 (US) and 5.6 and below (OUS)
Serial Numbers: HQ00105 through HQ01246 (see full list in description)
The hazard
The FDA said that running a Complete Blood Count with differential and reticulocyte sample immediately followed by another CBC+Diff sample on the same rack may generate falsely low red blood cell counts, falsely high Mean Cell Hemoglobin (MCH)/MCHC, and falsely low hematocrit results. Additionally, cell events may be incorrectly counted as basophils, resulting in increased basophil and percentage basophil counts.
Context
GovInfoNow's records show Abbott Laboratories has issued 33 other recalls since May 14, 2012. On Sept. 18, 2025, Abbott recalled Alinity hq Analyzers for a software issue that failed to flag results when saturation was present. Other recent recalls of similar products include Siemens Atellica CH A1c_E Hemoglobin Test May Give Low Results (Feb. 23, 2026), Siemens Atellica CH Urine Albumin Recall: False Results Risk (July 6, 2026), and Siemens Atellica CH A1c_E Test Recall: False HbA1c Results Risk (June 8, 2026).
How to tell if you have this one
Check your Alinity hq Analyzer's serial number against the list of affected units provided in the recall notice. The software version must be 5.7 (US) or 5.6 and below (OUS).
Brand
Abbott
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Software Version
Verify your Alinity hq Analyzer's software version is 5.7 (US) or 5.6 and below (OUS) by checking the device settings.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 3 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “Worldwide - US Nationwide distribution in the states of NY, OK, NC and the countries of ALBANIA, ARGENTINA, AUSTRALIA, BANGLADESH, BELGIUM, BOSNIA AND HERZEGOVINA, Botswana, BRAZIL, BULGARIA, CANADA, CAYMAN ISLANDS, CHILE, COLOMBIA,…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: New York, North Carolina, Oklahoma.
Recall timeline
FDA published this recall 2 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-2681-2024 (June 14, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2681-2024 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.