Class II

Medical Device Recall: Afinion 2 Analyzer, model #1116986, US refurbished, CLIA waived.

Abbott Diagnostics Technologies AS · June 17, 2024

Reason for Recall

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.

Distribution

US Nationwide distribution in the states of AZ, IN, MA, MN, and OH.

States Affected

NATIONWIDE

Quantity Affected

5 analyzers

Source: FDA (openFDA Device Enforcement)

Recall number: Z-2736-2024

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.