Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Rheumatoid Factor (RF) Kit for use on SPAPLUS Recalled by The Binding Site Group, Ltd. Due to The low and high controls for the product...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact The Binding Site Group, Ltd. directly.
Affected Products
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
Quantity: 49 kits to the U.S. office (32 kits further distributed)
Why Was This Recalled?
The low and high controls for the product are returning results above the assigned values.
Where Was This Sold?
This product was distributed to 1 state: CA
About The Binding Site Group, Ltd.
The Binding Site Group, Ltd. has 28 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report