Oslo, N/A, Norway
Abbott Diagnostics Technologies AS recalls
2 recalls recorded since 2018, most recently on 17 June 2024. 2 are listed as ongoing. Status and classification are as published by the FDA.
Recalls2
Ongoing (FDA)2
Terminated or completed0
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 17 June 2024
- 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.
- Distribution
- US Nationwide distribution in the states of AZ, IN, MA, MN, and OH.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2736-2024
- Afinion 2 Analyzer, model #1116986, US refurbished, CLIA waived.
Ongoing Class II Medical devices
- Recall started
- 23 March 2020
- Reason
- The analyzer system may have an electrostatic discharge and sparking of the power supply provided with the analyzers resulting in the power supply becoming non-functional.
- Distribution
- Distribution was made to NJ. There was no direct government/military distribution. Foreign distribution was made to Canada, Argentina, Australia, Bangladesh, Brazil, Cambodia, Chile, China, Colombia, Denmark, Finland, France, Georgia, Germany, Guatemala, Hong Kong, Iceland, India, Italy, Ivory C
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2192-2020
- Power supply provided with Afinion 2, Catalog numbers 1116553, 1116554, 1116556, 1116557, 1116597, 1116598, 1116663, 1116679, 1116680, 1116681, 1116682, 1116684, 1116770, 1116771, 1116772, 1116777, 1116778, 1116970, 1116
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.