Randox recalls calcium reagents that may cause false high or low test results. Affected products include specific lot codes of the Randox Calcium Colorimetric Method RX Series.
Update to the carryover avoidance technical bulletin to introduce additional steps for reagent carryover avoidance with the Calcium assay on RX instruments. Carryover to the Calcium reagent results may result in falsely elevated or decreased results to both patient and QC samples.
Randox is recalling calcium reagents that could give false high or low test results if carryover occurs. This affects lab tests for calcium levels in patient and quality control samples.
The reagents may have carryover between tests, causing false high or low calcium results in patient and quality control samples. This happens due to improper cleaning between tests on the RX instruments.
Lab users who test calcium levels with the Randox Calcium Colorimetric Method RX Series reagents are affected. Those handling patient samples or QC samples at labs using these reagents are most at risk.
Check for the product name 'Randox CALCIUM (Ca) Colorimetric Method RX Series Cat. No. CA 3871, R1. Arsenazo Reagent 9 x 51ml' with GTIN 05055273200904. All lot codes are affected.
Identify the lot code on the reagent container to confirm if it's affected.
The reagent may cause false high or low calcium test results due to carryover between tests on RX instruments.
Check for the product name 'Randox CALCIUM (Ca) Colorimetric Method RX Series Cat. No. CA 3871, R1. Arsenazo Reagent 9 x 51ml' with GTIN 05055273200904. All lot codes are affected.
The recall record does not specify a remedy, so contact Randox directly for guidance.
We’ve drafted a message you can send Randox to request your refund or repair — edit it as you like.
Subject: Recall Z-0839-2019 — Randox Randox Hello, I own a Randox that is covered by recall Z-0839-2019 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.
