Home / Recalls / Medical Devices
Abbott Diagnostics Technologies AS recalls Afinion 2 Analyzer, model #1116986, US refurbished, CLIA waived.
Recalled September 4, 2024 · FDA recall Z-2736-2024 · Abbott Diagnostics Technologies AS
Hazard
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. · FDA Class II
Units
5 analyzers
Sold at
US Nationwide distribution in the states of AZ, IN, MA, MN, and OH.
Description
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.
Product
Afinion 2 Analyzer, model #1116986, US refurbished, CLIA waived.
Manufacturer(s)
Abbott Diagnostics Technologies AS
Made in
Norway
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →