Abbott Diagnostics Technologies AS: Medical Device Recall in 2024 - (Recall #: Z-2736-2024)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2024.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: June 17, 2024

Date Posted: September 4, 2024

Recall Number: Z-2736-2024

Event ID: 94910

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.

Status: Ongoing

Product Quantity: 5 analyzers

Code Information:

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

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated