Home / Recalls / Abbott Diagnostics Technologies AS / Z-2736-2024

Z-2736-2024 Class II Ongoing

Recalled by Abbott Diagnostics Technologies AS — Oslo

Recall Details

Product Type: Devices
Report Date: September 4, 2024
Initiation Date: June 17, 2024
Termination Date: N/A
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 5 analyzers

Product Description

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 Pattern

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

Code Information

Lot #433706, Serial numbers AF20008880, AF20002691, AF20035414, AF20015543 and AF20035460; UDI-DI: 07070060014708.