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.
The Binding Site Group recalls a Rheumatoid Factor (RF) Kit for use on SPAPLUS that may produce false positive test results. This could lead to unnecessary additional serological testing for patients.
The RF calibrator values over recover compared to reference material, causing false abnormal results. This may lead to unnecessary additional serological testing for patients.
Patients using the RF Kit for in-vitro diagnostic testing are affected. Those with autoimmune conditions may be at higher risk due to potential false positives.
Check for product code LK151.S.A. and UDI: 05051700018319. Lot 428217 (expiring April 30, 2020) is affected.
Verify the product code LK151.S.A. and UDI: 05051700018319 to confirm if your kit is affected.
The kit may produce false positive results, leading to unnecessary additional testing.
Check for product code LK151.S.A. and UDI: 05051700018319. Lot 428217 (expiring April 30, 2020) is affected.
No action is required as the hazard is low risk and only affects specific kits.
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-1500-2020 — The Binding Site Group The Binding Site Group Hello, I own a The Binding Site Group that is covered by recall Z-1500-2020 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.
