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The Binding Site Group, Ltd. recalls Rheumatoid Factor (RF) Kit for use on SPAPLUS, for in-vitro diagnostic use, Product code: LK151.S.A. , UDI: 050517000183
Recalled March 25, 2020 · FDA recall Z-1500-2020 · The Binding Site Group
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. · FDA Class II
Units
30 kits
Sold at
Distributed in CA.
Description
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.
Product
Rheumatoid Factor (RF) Kit for use on SPAPLUS, for in-vitro diagnostic use, Product code: LK151.S.A. , UDI: 05051700018319
Manufacturer(s)
The Binding Site Group, Ltd.
Made in
United Kingdom
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →