Randox recalls RX Imola (RX490:00) lab analyzers for professional use due to software issues that could delay test results. All units are affected.
Abnormal premature termination of the software could affect the use of the analyser when running patient samples. The impact being a delay in reporting test results.
Randox is recalling its RX Imola (RX4900) lab analyzers for professional use because software errors might delay test results. This affects healthcare facilities using these devices for clinical testing.
The software may terminate prematurely during patient sample analysis, causing delays in test result reporting. This does not cause physical harm but could impact timely medical decisions.
Healthcare facilities that use Randox RX Imola (RX4900) analyzers for clinical testing are affected. Staff and patients are at low risk due to the delay in reporting results rather than immediate harm.
Check for the RX Imola (RX4900) model with GTIN 05055273206104. All units are affected, including those with any serial number.
Look for premature software termination during patient sample runs, which may cause delays in test results.
Yes, the recall affects all Randox RX Imola (RX4900) analyzers used for clinical testing, which may cause delays in reporting test results.
All RX Imola (RX4900) analyzers with GTIN 05055273206104 are affected, regardless of serial number.
No, the recall does not require immediate discontinuation. The issue causes delays in test results, not immediate safety risks.
We’ve drafted a message you can send Randox to request your refund or repair — edit it as you like.
Subject: Recall Z-2059-2018 — Randox Randox Hello, I own a Randox that is covered by recall Z-2059-2018 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.
