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The Binding Site Group, Ltd. recalls Rheumatoid Factor (RF) Kit for use on SPAPLUS, Product #LK151.S.A Intended for the quantitative in-vitro measurement
Recalled February 14, 2018 · FDA recall Z-0553-2018 · The Binding Site Group
Hazard
The low and high controls for the product are returning results above the assigned values. · FDA Class II
Units
49 kits to the U.S. office (32 kits further distributed)
Sold at
US Distribution was made to CA. There was no foreign/military/government distribution.
Description
The low and high controls for the product are returning results above the assigned values.
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
Manufacturer(s)
The Binding Site Group, Ltd.
Made in
United Kingdom
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →