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.
The Binding Site Group recalls their Optilite Rheumatoid Factor Kit because it can produce false positive results for rheumatoid arthritis tests. This might lead to extra testing and delays in treatment for patients.
The kit's calibrator value for rheumatoid factor (RF) is 7% higher than the reference material. This difference can cause the test to report false positive results, meaning patients might get unnecessary additional tests and treatment delays.
Patients using the Optilite Rheumatoid Factor Kit for rheumatoid arthritis testing may be affected. Those who have recently received the kit are most at risk of unnecessary testing and delayed treatment.
Check for the kit's unique identifier (UDI): 05051700020015. The kit contains four components and was sold with lot number 428224.
Verify the kit's unique identifier (UDI) and lot number to confirm if it's recalled.
The kit's calibrator value for rheumatoid factor (RF) is 7% higher than the reference material, which can cause false positive results in rheumatoid arthritis testing.
False positive results may lead to unnecessary additional tests and delays in treatment for rheumatoid arthritis.
Look for the unique identifier (UDI) 05051700020015 and lot number 428224 on the kit.
We’ve drafted a message you can send The Binding Site Group to request your refund or repair — edit it as you like.
Subject: Recall Z-2110-2020 — The Binding Site Group The Binding Site Group Hello, I own a The Binding Site Group that is covered by recall Z-2110-2020 from The Binding Site Group. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
