Randox recalls specific batches of Rheumatoid Factor Standard (RF CAL) test kits due to calibration errors that could affect rheumatoid arthritis diagnosis accuracy. Affected kits may provide incorrect results if used without proper calibration.
The assigned value for Rheumatoid Factor over recovers against the reference material RF serum, 1st British standard from NIBSC. Ref = 64/002. The calibrator values have been adjusted to re-align to the reference material.
Randox is recalling specific batches of Rheumatoid Factor Standard (RF CAL) test kits because their calibration values no longer match the reference standard. This could lead to inaccurate rheumatoid arthritis test results if the kits are used without proper recalibration.
The test kits were calibrated to a standard that no longer matches the reference material used in the UK's National Institute for Biological Standards and Control (NIBSC). This mismatch could cause inaccurate rheumatoid factor measurements, potentially leading to incorrect diagnosis of rheumatoid arthritis.
Lab personnel using the specific batch numbers listed in the recall notice. Patients relying on these kits for rheumatoid arthritis diagnosis may be at risk of incorrect test results.
Check for batch numbers 463479/1325-1329RF, 466715/1325-1329RF, 474059/1339-1343RF, or 480410/1347-1351RF on the test kit packaging. The product is a rheumatoid factor test kit used in laboratories for diagnosing rheumatoid arthritis.
Look for batch numbers 463479/1325-1329RF, 466715/1325-1329RF, 474059/1339-1343RF, or 480410/1347-1351RF on the test kit packaging.
The calibration values for the test kit no longer match the reference standard used by the National Institute for Biological Standards and Control (NIBSC), which could lead to inaccurate rheumatoid arthritis test results.
Check the batch number on the kit. If it matches the recalled batch numbers, contact Randox Laboratories for guidance on next steps.
This recall affects laboratory personnel using the test kits. Patients using the test kits for diagnosis may receive inaccurate results if the kits are not properly calibrated.
We’ve drafted a message you can send Randox to request your refund or repair — edit it as you like.
Subject: Recall Z-0282-2020 — Randox Randox Hello, I own a Randox that is covered by recall Z-0282-2020 from Randox. 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.
