Randox recalls liquid protein calibrators (SP CAL (LIQ)) due to inaccurate Rheumatoid Factor measurements. Affected units may cause incorrect test results for certain blood tests.
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 liquid protein calibrators used in blood tests because they provide inaccurate Rheumatoid Factor measurements. This could lead to incorrect test results for certain blood tests.
The calibrators have been adjusted to re-align to the reference material, but the assigned value for Rheumatoid Factor over recovers against the reference material. This means the calibrators may provide inaccurate Rheumatoid Factor measurements, potentially leading to incorrect test results.
Healthcare professionals using these calibrators for blood tests are affected. The risk is low as the issue only affects test accuracy, not safety.
Look for the product name 'Liquid Protein Calibrators (SP CAL (LIQ))' with Catalogue Number IT2691 and GTIN 05055273204032. The affected batches include 440973 /1748, 1752IT, 451414 /1748, 1752IT, 470531 /1813, 1817IT, and 480859 /1813, 1817IT.
Verify the Catalogue Number (IT2691) and GTIN (05055273204032) on the product label.
The calibrators may provide inaccurate Rheumatoid Factor measurements, which could lead to incorrect test results for certain blood tests.
The recall does not specify a remedy, so no action is required unless you are using the product for blood tests and want to ensure accurate results.
The calibrators are used for in vitro diagnostic tests on Clinical Chemistry and Immunoassay systems, including ASO, Complement C3, Complement C4, CRP, Ferritin, Haptoglobin, IgA, IgG, IgM, Prealbumin, and Transferrin assays.
We’ve drafted a message you can send Randox to request your refund or repair — edit it as you like.
Subject: Recall Z-0283-2020 — Randox Randox Hello, I own a Randox that is covered by recall Z-0283-2020 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.
