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 It has been identified that the rheumatoid factor...
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, for in-vitro diagnostic use, Product code: LK151.S.A. , UDI: 05051700018319
Quantity: 30 kits
Why Was This Recalled?
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.
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