Alinity hq Analyzer May Generate Incorrect Blood Test Results
Abbott's Alinity hq Analyzer has been recalled due to software issues that can produce incorrect blood cell counts and hemoglobin measurements in certain circumstances. No illnesses have been reported.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This FDA Class II recall involves a diagnostic analyzer with software defects that could produce incorrect laboratory results (false blood counts, hemoglobin values, basophil counts), representing a risk of harm through potential misdiagnosis. No illnesses or injuries have been reported, placing this in the High category per the rubric for risk-of-harm medical devices without reported injury.
Plain-English summary
Abbott Laboratories is recalling the Alinity hq Analyzer (REF: 09P68-01) due to software defects that can produce incorrect laboratory results. The recall affects 816 devices distributed worldwide, including in the United States (New York, Oklahoma, North Carolina) and multiple countries.
The analyzer may generate falsely low red blood cell counts and falsely high mean cell hemoglobin (MCH) and mean corpuscular hemoglobin concentration (MCHC) values when a Complete Blood Count with differential and reticulocyte sample is immediately followed by a CBC with differential sample on the same rack. Additionally, cell events may be incorrectly counted as basophils, resulting in elevated basophil counts and percentages. These errors could compromise diagnostic accuracy.
No illnesses or injuries have been reported. The FDA classified this as a Class II recall. Healthcare facilities and laboratories using affected Alinity hq Analyzer devices should contact Abbott Laboratories for instructions on software updates or device replacement.
The recalled product
- Product
- Alinity hq Analyzer, REF: 09P68-01
- Manufacturer
- Abbott Laboratories
- Hazard
- incorrect-results
- hematology-error
- software-defect
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- UDI-DI: 380740138851. Software Versions: 5.7 (US) and 5.6 and below (OUS)
- Serial Numbers: HQ00105
- HQ00108
- HQ00117
- HQ00118
- HQ00119
- HQ00120
- HQ00126
- HQ00127
- HQ00128
- HQ00132
- HQ00136
- HQ00139
- HQ00140
- HQ00141
- HQ00142
- HQ00144
- HQ00145
- HQ00147
- HQ00148
Distribution
Distributed nationwide across the United States.
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