Device product
Human Lambda Free SPAPlus Kit Product Code: LK018.S Freelite aids in the detection and monitoring of Multiple Myeloma and related diseases.
Z-1050-2017
Product summary
- Event
- Event 76049
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1,002
- Official record key
device-enforcement:Z-1050-2017
Official wording
Reason: Calibration curve activity has increased over time in the kit lots listed.
Code information: Lot #323278, 327963
Distribution pattern: U.S. distribution to the following; CA, TX, HI, GA, PA, UT, NY, OK, ID, MA, AZ. Foreign distribution to the following; Australia, Bulgaria, Denmark, Hong Kong, Ireland, Israel, Japan, New Zealand, Taiwan, Belgium, France, Italy, Spain.
Derived failure modes
-
Unknown
Calibration curve activity has increased over time in the kit lots listed.