The Binding Site Group recalls Rheumatoid Factor Kit: Low/High Controls Return Invalid
The Binding Site Group recalls Rheumatoid Factor (RF) Kit for SPAPLUS analyser due to low and high controls returning results above assigned values. This may affect rheumatoid arthritis testing accuracy.
Lower-risk recall
The low and high controls for the product are returning results above the assigned values.
Contact the company
What happened, in plain English
The Binding Site Group recalls their Rheumatoid Factor (RF) Kit for SPAPLUS analyser because the low and high control samples give results higher than expected. This could lead to inaccurate rheumatoid arthritis test results if used without correction. Read more at govinfonow.com/recall/72170-the-binding-site-group-recalls-rheumatoid-factor-kit-low-high.
Source Summary by GovInfoNow · govinfonow.com/recall/72170-the-binding-site-group-recalls-rheumatoid-factor-kit-low-high · Updated August 31, 2026 · FDA enforcement record: FDA #Z-0553-2018
Cite this page
“The Binding Site Group recalls Rheumatoid Factor Kit: Low/High Controls Return Invalid.” GovInfoNow, updated August 31, 2026. https://govinfonow.com/recall/72170-the-binding-site-group-recalls-rheumatoid-factor-kit-low-high. Based on FDA recall #Z-0553-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0553-2018%22&limit=1).
Why it’s dangerous
The low and high control samples in the kit produce results that exceed the expected values. This could cause inaccurate measurements of rheumatoid factor in serum, potentially leading to incorrect diagnosis or treatment decisions.
Who’s affected
People using this kit for rheumatoid arthritis testing may be affected. Those with rheumatoid arthritis who rely on accurate lab results are most at risk.
How to tell if you have this one
Check for the product name 'Rheumatoid Factor (RF) Kit for SPAPLUS', product number LK151.S.A, and lot number 416595 (expired 31/03/2018).
- Brand
The Binding Site Group- Category
Medical device
What to do — step by step
Check Kit Details
Verify the product number LK151.S.A and lot number 416595 on the kit label.
Where it went and when
Where it was distributed
Distributed in California.
FDA distribution: “US Distribution was made to CA. There was no foreign/military/government distribution.” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: California.
Recall timeline
FDA terminated this recall 2.4 years after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-0553-2018 (January 4, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0553-2018 to see it in context.
- Plain-language summary written by qwen3:4b on August 31, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.