Abbott Diagnostics Technologies AS: Device Recall
Recall #Z-2736-2024 · 06/17/2024
Class II: Risk
Recall Details
- Recall Number
- Z-2736-2024
- Classification
- Class II
- Product Type
- Device
- Recalling Firm
- Abbott Diagnostics Technologies AS
- Status
- Ongoing
- Date Initiated
- 06/17/2024
- Location
- Oslo, Norway
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 5 analyzers
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.
Product Description
Afinion 2 Analyzer, model #1116986, US refurbished, CLIA waived.
Distribution Pattern
US Nationwide distribution in the states of AZ, IN, MA, MN, and OH.
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.