Randox recalls calcium test kits that may give false high or low results due to reagent carryover. Affected kits include specific model numbers and lot codes. Contact Randox for details.
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 test kits that could produce inaccurate results if reagent carryover occurs. This means test results for patients and quality control samples might be too high or too low.
The calcium test kits may have reagent carryover, where leftover reagent from one test contaminates the next. This can cause test results to be too high or too low for both patient samples and quality control checks.
Lab users who test with Randox calcium kits may be affected. Those handling the kits without proper steps could see inaccurate results.
Check for the model number CA 8309 R1 and lot codes on the kit. The kits were sold with GTIN 05055273208368 and all lot codes.
Look for the model number CA 8309 R1 and lot codes on the kit.
The recall is due to a risk of false results from reagent carryover in calcium tests, which could lead to inaccurate patient and quality control results.
Check for the model number CA 8309 R1 and lot codes on the kit. The kits were sold with GTIN 05055273208368 and all lot codes.
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-0840-2019 — Randox Randox Hello, I own a Randox that is covered by recall Z-0840-2019 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.
