FDA-Device2024-09-04Class II
Afinion 2 Analyzer, model #1116986, US refurbished, CLIA waived.
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.
Sold states
US Nationwide distribution in the states of AZ, IN, MA, MN, and OH.
Affected count
5 analyzers
Manufactured in
Kjelsasveien 161, Oslo, Norway
Products
Afinion 2 Analyzer, model #1116986, US refurbished, CLIA waived.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2736-2024Don't want to check this manually?
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