Lower riskMedical device recall · FDA · Published March 9, 2018
The Binding Optilite Beta-2-Microglobulin Urine Kit Recall: Inaccurate Test Results
The Binding Site Group recalls their Optilite Beta-2-Microglobulin Urine Kit (Ref LK043.L.OPT.A) due to inaccurate test results. This IVD kit may not meet the claimed antigen excess protection level of 760mg/L, potentially leading to incorrect diagnosis of rheumatoid arthritis or kidney disease.
The product is not meeting the antigen excess protection claim of up to 760mg/L, as stated in the Instructions for Use.
Take action
Contact the company
📍Recalling firmThe Binding Site Group, Ltd.8 Calthorpe Road · Birmingham, United Kingdom
✎ GovInfoNow plain-language explainer
The Binding Site Group is recalling their Optilite Beta-2-Microglobulin Urine Kit (Ref LK043.L.OPT.A) because it may not provide accurate test results as claimed. This could lead to incorrect diagnosis of rheumatoid arthritis or kidney disease if used without proper validation. Read more at govinfonow.com/recall/71742-the-binding-optilite-beta-2-microglobulin-urine-kit-recall-inaccurate.
“The Binding Optilite Beta-2-Microglobulin Urine Kit Recall: Inaccurate Test Results.” GovInfoNow, updated August 28, 2026. https://govinfonow.com/recall/71742-the-binding-optilite-beta-2-microglobulin-urine-kit-recall-inaccurate. Based on FDA recall #Z-1301-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1301-2018%22&limit=1).
The FDA announced on March 9, 2018, that The Binding Site Group, Ltd. voluntarily recalled its Optilite Beta-2-Microglobulin Urine Kit because it fails to meet the antigen excess protection claim stated in the instructions for use.
How to tell if you have it
Brand: The Binding
Product: Binding Site Optilite Beta-2-Microglobulin Urine Kit, Ref LK043.L.OPT.A, IVD
Lot code: 407460
UDI: 05051700017688
The hazard
The product is not meeting the antigen excess protection claim of up to 760mg/L, as stated in the Instructions for Use.
Context
GovInfoNow's records show The Binding Site Group, Ltd. has had 15 other recalls since August 23, 2017. Other recent recalls of similar products include Siemens Atellica CH Urine Albumin Recall (July 6, 2026), Bioporto ProNephro AKI Reagent Kit Recall (May 18, 2026), and Changchun Wancheng Bio-Electron UTI Test Strips Recall (Nov. 22, 2025).
How to tell if you have this one
Check for the product name 'Optilite Beta-2-Microglobulin Urine Kit' with reference number LK043.L.OPT.A. The kit was sold with lot number 407460 and unique device identifier 05051700017688.
Brand
The Binding
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Product Details
Verify the product name, reference number, lot number, and unique device identifier on the kit label.
Where it went and when
Where it was distributed
Distributed in California.
Listed by the agency
Not listed
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 2.3 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-1301-2018 (March 9, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1301-2018 to see it in context.
Plain-language summary written by qwen3:4b on August 28, 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.