Device product
Afinion 2 Analyzer, model #1116986, US refurbished, CLIA waived.
Z-2736-2024
Product summary
- Event
- Event 94910
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 5 analyzers
- Official record key
device-enforcement:Z-2736-2024
Official wording
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 information: Lot #433706, Serial numbers AF20008880, AF20002691, AF20035414, AF20015543 and AF20035460; UDI-DI: 07070060014708.
Distribution pattern: US Nationwide distribution in the states of AZ, IN, MA, MN, and OH.
Derived failure modes
-
Unknown
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.