Device product
Freelite Human Lambda Free Kit for use on SPAPLUS Product Code: LK018.S, LK018.10S Freelite aids the detection and monitoring of Multiple Myeloma and related diseases
Z-1053-2017
Product summary
- Event
- Event 76050
- Status
- Terminated
- Classification
- Class II
- Quantity
- 3,088
- Official record key
device-enforcement:Z-1053-2017
Official wording
Reason: A change in the calibration curve causing an increase in false prozone flags.
Code information: Lot #400012, 400257
Distribution pattern: Worldwide Distribution - U.S. (nationwide) and Internationally to the following; Canada, Australia.
Derived failure modes
-
Unknown
A change in the calibration curve causing an increase in false prozone flags.