FDA recall Z-2736-2024

Product

Afinion 2 Analyzer, model #1116986, US refurbished, CLIA waived.

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.

Key facts

Status

Ongoing

Initiation date

2024-06-17

Report date

2024-09-04

Voluntary/Mandated

Voluntary: Firm initiated

Location

Oslo, Norway

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2736-2024