Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Afinion 2 Analyzer Recalled by Abbott Diagnostics Technologies AS Due to Five Afinion 2 (AF2) Analyzer were incorrectly market...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Abbott Diagnostics Technologies AS directly.
Affected Products
Afinion 2 Analyzer, model #1116986, US refurbished, CLIA waived.
Quantity: 5 analyzers
Why Was This Recalled?
Five Afinion 2 (AF2) Analyzer were incorrectly market configured as Moderate Complexity and distributed to customers. Use of moderately complex assays by waived laboratories could result in erroneous results.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Abbott Diagnostics Technologies AS
Abbott Diagnostics Technologies AS has 2 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report