Recall Z-2736-2024— Abbott Diagnostics Technologies AS

Name: FDA recall Z-2736-2024
Creator: U.S. Food and Drug Administration
Published: 2024-06-17

Class II · Ongoing

Class II FDA medical device recall by Abbott Diagnostics Technologies AS, initiated 2024-06-17. It names one FDA 510(k) clearance: K171650. Product: Afinion 2 Analyzer, model #1116986, US refurbished, CLIA waived.. Reason: 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..

Recalling firm: Abbott Diagnostics Technologies AS
Classification: Class II
Status: Ongoing
Initiated: 2024-06-17
Firm location: Oslo, Norway

510(k) clearances named in this recall

1 on FDA's record

K171650 — Alere Afinion HbA1c and ACR on Afinion 2 analyzerAbbott Rapid Diagnostics·cleared 2017-11-21

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.