FDA-Device2020-03-25Class II
Rheumatoid Factor (RF) Kit for use on SPAPLUS, for in-vitro diagnostic use, Product code: LK151.S.A. , UDI: 05051700018319
The Binding Site Group, Ltd.
Hazard
It has been identified that the rheumatoid factor (RF) calibrator values over recover in comparison to the reference material RF serum. This could result in reporting falsely abnormal results which may lead to unnecessary additional serological testing.
Sold states
Distributed in CA.
Affected count
30 kits
Manufactured in
8 Calthorpe Road, Birmingham, United Kingdom
Products
Rheumatoid Factor (RF) Kit for use on SPAPLUS, for in-vitro diagnostic use, Product code: LK151.S.A. , UDI: 05051700018319
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1500-2020Don't want to check this manually?
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