Abbott Diagnostics Technologies AS: Afinion 2 Analyzer, model #1116986, US refurbished, CLIA waived.

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.

Details from the source

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. Quantity: 5 analyzers Lot/code info: Lot #433706, Serial numbers AF20008880, AF20002691, AF20035414, AF20015543 and AF20035460; UDI-DI: 07070060014708.

UPC codes

07070060014708

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.