Lower riskMedical device recall · FDA · Published October 7, 2019
Optilite Rheumatoid Factor Kit Recall: False Positive Test Results Risk
The Binding Site Group recalls Optilite Rheumatoid Factor Kit (UDI: 05051700020015) due to potential false positive results in rheumatoid arthritis testing, which may cause unnecessary tests and delayed treatment.
Assigned Rheumatoid Factor (RF) calibrator value for calibrator component included in kit used to aid in the diagnosis of rheumatoid arthritis over recovers by 7% in comparison to the reference material RF serum. This could result in reporting abnormal (false positive) results, which may lead to unnecessary additional serological testing and a delay in treatment.
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Contact the company
📍Recalling firmThe Binding Site Group, Ltd.8 Calthorpe Road · Birmingham, United Kingdom
“Optilite Rheumatoid Factor Kit Recall: False Positive Test Results Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/66879-optilite-rheumatoid-factor-kit-recall-false-positive-test-results-risk. Based on FDA recall #Z-2110-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2110-2020%22&limit=1).
The FDA announced on 2019-10-07 that The Binding Site Group, Ltd. voluntarily recalled Optilite Rheumatoid Factor Kits due to potential false positive results. This classification II recall affects 478 kits distributed in several U.S. states.
The calibrator component in the kit may overrecover by 7% compared to reference material, potentially causing false positive results. This error could lead to unnecessary additional serological testing and a delay in treatment for rheumatoid arthritis diagnosis.
Context
GovInfoNow's records show The Binding Site Group, Ltd. has had 15 other recalls since 2017-08-23. Recent brand recalls include the EXENT Analyser Software Version 1.0.20 recall on 2026-04-16 and the Freelite Human Lambda Free Kit Recall on 2021-10-15. Other recent recalls of similar products include Immunotech Estrone RIA Kit Recall (2025-12-15), BioFire Joint Infection Panel Recall (2026-04-22), and Biomerieux VITEK 2 AST-N461 Test Kit Recall (2026-07-24).
How to tell if you have this one
Check for the kit's unique identifier (UDI): 05051700020015. The kit contains four components and was sold with lot number 428224.
Brand
The Binding Site Group
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Kit Details
Verify the kit's unique identifier (UDI) and lot number to confirm if it's recalled.
Where it went and when
Where it was distributed
Distributed in 20 states.
Listed by the agency
Not listed
FDA distribution: “US: AL, AR, AZ, FL, GA, KY, MA, MD, MI, MN, MS, NC, NE, NY, OR, PA, TX, VT, WA, WI OUS: None” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Alabama, Arizona, Arkansas, Florida, Georgia, Kentucky, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Nebraska, New York, North Carolina, Oregon, Pennsylvania, Texas, Vermont, Washington, Wisconsin.
Recall timeline
FDA terminated this recall 2.3 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-2110-2020 (October 7, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2110-2020 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.