Lower riskMedical device recall · FDA · Published November 6, 2019
The Binding Site Group Recalls RF Kit for False Test Results
The Binding Site Group recalls Rheumatoid Factor (RF) Kit for false positive test results due to calibrator values over recovering. Affected kits may cause unnecessary testing.
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.
Take action
Contact the company
📍Recalling firmThe Binding Site Group, Ltd.8 Calthorpe Road · Birmingham, United Kingdom
“The Binding Site Group Recalls RF Kit for False Test Results.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/66558-the-binding-site-group-recalls-rf-kit-for-false-test. Based on FDA recall #Z-1500-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1500-2020%22&limit=1).
The Food and Drug Administration announced on 2019-11-06 that The Binding Site Group, Ltd. is recalling the Rheumatoid Factor (RF) Kit for use on SPAPLUS due to a Class II hazard. The calibrator values may over recover, potentially leading to falsely abnormal results and unnecessary additional testing.
How to tell if you have it
Brand: The Binding Site Group
Product: Rheumatoid Factor (RF) Kit for use on SPAPLUS
Product code: LK151.S.A.
UDI: 05051700018319
Lot: 428217
Expiry date: 30-APR-2020
Quantity: 30 kits
Distribution: CA
The hazard
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.
Context
GovInfoNow's records show The Binding Site Group, Ltd. has 15 other recalls on record since 2017-08-23. Other recent recalls of similar products include Immunotech Estrone RIA Kit Recall (2025-12-15), Sperm Ab ELISA Test Kit Recall (2026-07-02) and BioFire Joint Infection Panel Recall (2026-04-22).
How to tell if you have this one
Check for product code LK151.S.A. and UDI: 05051700018319. Lot 428217 (expiring April 30, 2020) is affected.
Brand
The Binding Site Group
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Product Details
Verify the product code LK151.S.A. and UDI: 05051700018319 to confirm if your kit is affected.
Where it went and when
Where it was distributed
Distributed in California.
Listed by the agency
Not listed
FDA distribution: “Distributed in CA.” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: California.
Recall timeline
FDA terminated this recall 2.8 years after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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-1500-2020 (November 6, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1500-2020 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 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.