Abbott Diagnostics Technologies AS recalls Afinion 2 Analyzer, model #1116986, US refurbished, CLIA waived.
- Recall date
- June 17, 2024
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-2736-2024
- FDA classification
- Class II
- Brand / firm
- Abbott Diagnostics Technologies AS
- Sold / distributed
- US Nationwide distribution in the states of AZ, IN, MA, MN, and OH.
Why it was 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.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
Afinion 2 Analyzer, model #1116986, US refurbished, CLIA waived.
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