Device product
Rheumatoid Factor (RF) Kit for use on SPAPLUS, Product #LK151.S.A Intended for the quantitative in-vitro measurement of rheumatoid factor in serum using the Binding Site SPAPLUS analyser. Measurement of rheumatoid factor may aid in the diagnosis of rheumatoid arthritis. This test should be used in conjunction with other laboratory and clinical findings
Z-0553-2018
Product summary
- Event
- Event 78934
- Status
- Terminated
- Classification
- Class II
- Quantity
- 49 kits to the U.S. office (32 kits further distributed)
- Official record key
device-enforcement:Z-0553-2018
Official wording
Reason: The low and high controls for the product are returning results above the assigned values.
Code information: Lot #416595, Exp. 31/03/2018; UDI #05051700018319
Distribution pattern: US Distribution was made to CA. There was no foreign/military/government distribution.
Derived failure modes
-
Unknown
The low and high controls for the product are returning results above the assigned values.