Randox recalls Calibration Serum Level 3 (CAL 3) with batch 1162UE due to potential positive bias in bilirubin tests. Affected users should check their batch numbers and contact Randox for guidance.
Randox can confirm a positive bias for Total Bilirubin and Direct Bilirubin of up to +15% across the assay ranges when using calibrator CAL2351, lot 1162UE. The positive bias has been attributed to bilirubin instability in the calibrator and is evident in both Quality Control (QC) and Patient samples.
Randox is recalling Calibration Serum Level 3 (CAL 3) with batch number 1162UE because it can cause bilirubin test results to be up to 15% higher than actual. This may lead to inaccurate medical diagnoses if used in patient testing.
The calibration serum can cause bilirubin test results to be up to 15% higher than true values. This positive bias affects both quality control samples and patient samples, potentially leading to incorrect medical diagnoses.
Users of this calibration serum in medical labs or clinical testing facilities who run patient tests. Those using the serum for bilirubin measurements are most at risk of inaccurate results.
Check for the batch number 1162UE on the Calibration Serum Level 3 (CAL 3) product. The product has catalogue number CAL2351 and GTIN 05055273200966.
Look for the batch number 1162UE on the Calibration Serum Level 3 (CAL 3) product.
Randox confirms a positive bias for Total Bilirubin and Direct Bilirubin of up to +15% across assay ranges when using calibrator CAL2351, lot 1162UE.
The recall record does not specify a remedy, so contact Randox directly for guidance.
Check for the batch number 1162UE on the Calibration Serum Level 3 (CAL 3) product, which has catalogue number CAL2351 and GTIN 05055273200966.
We’ve drafted a message you can send Randox to request your refund or repair — edit it as you like.
Subject: Recall Z-1563-2021 — Randox Randox Hello, I own a Randox that is covered by recall Z-1563-2021 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.
