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
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.
The analyzer may show falsely low red blood cell counts and falsely high Mean Cell Hemoglobin (MCH) and MCHC values when a CBC+Diff+Retic test is run immediately followed by another CBC+Diff test. It can also miscount cells as basophils, increasing basophil counts.
Healthcare facilities using the recalled Alinity hq Analyzers with software versions 5.7 (US) or 5.6 and below (OUS) are most at risk. Patients receiving blood tests on these devices could receive inaccurate results.
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).
Verify your Alinity hq Analyzer's software version is 5.7 (US) or 5.6 and below (OUS) by checking the device settings.
The recall is due to the analyzer potentially producing false low red blood cell counts and miscounting basophils when specific blood tests are run in sequence.
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).
The recall does not specify a remedy, so contact Abbott Laboratories directly for guidance on next steps.
We’ve drafted a message you can send Abbott to request your refund or repair — edit it as you like.
Subject: Recall Z-2681-2024 — Abbott Abbott Hello, I own a Abbott that is covered by recall Z-2681-2024 from Abbott. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
