The Binding Site Group, Ltd. recalls Rheumatoid Factor (RF) Kit for use on SPAPLUS, for in-vitro
Recalled Product
Rheumatoid Factor (RF) Kit for use on SPAPLUS, for in-vitro diagnostic use, Product code: LK151.S.A. , UDI: 05051700018319
Hazard / Issue
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.
Issued by
FDA
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