Z-2736-2024 Class II Ongoing
FDA device recall Z-2736-2024 was initiated by Abbott Diagnostics Technologies AS on June 17, 2024 and is designated Class II. 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 … The recall status is ongoing. Affected quantity: 5 analyzers.
Recall Details
- Product Type
- Devices
- Report Date
- September 4, 2024
- Initiation Date
- June 17, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 5 analyzers
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.
Distribution Pattern
US Nationwide distribution in the states of AZ, IN, MA, MN, and OH.
Code Information
Lot #433706, Serial numbers AF20008880, AF20002691, AF20035414, AF20015543 and AF20035460; UDI-DI: 07070060014708.