FDA Enforcement
Class II
Ongoing
Afinion 2 Analyzer, model #1116986, US refurbished, CLIA waived.
Recall: Z-2736-2024
·
Reported September 4, 2024
Enforcement
- Recall Number
- Z-2736-2024
- Event ID
- 94910
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Abbott Diagnostics Technologies AS
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- September 4, 2024
- Initiation Date
- June 17, 2024
- Classification Date
- August 27, 2024
- Address
- Kjelsasveien 161, Oslo, N/A, Norway
Description
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.
Code Info
Lot #433706, Serial numbers AF20008880, AF20002691, AF20035414, AF20015543 and AF20035460; UDI-DI: 07070060014708.
Distribution
US Nationwide distribution in the states of AZ, IN, MA, MN, and OH.
Quantity
5 analyzers