RX Monaco-IVD Clinical Chemistry Analyzer rerun feature may report incorrect results
Randox Laboratories is recalling 13 RX Monaco-IVD Clinical Chemistry Analyzers with a rerun feature defect that may report incorrect test results when samples are outside normal assay range. Units were distributed nationwide including Puerto Rico.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall with no reported illnesses or injuries. However, it involves a medical device that may report test results incorrectly, creating a risk of harm to patients from potential misdiagnosis.
Plain-English summary
Randox Laboratories Ltd. is recalling 13 RX Monaco-IVD Clinical Chemistry Analyzers (Catalog Number RX5000) due to a defect in the rerun feature. The affected units were distributed nationwide including Puerto Rico.
The rerun settings (specifically sample volume low/high and dilutions for automatic reruns) do not properly meet rerun conditions when samples are above or below the assay range. This defect may result in test results being reported incorrectly.
Healthcare facilities and laboratories that received affected units should verify their device lot numbers against the recall notice and contact Randox Laboratories if their equipment matches one of the identified batch numbers.
The recalled product
- Product
- RX Monaco-IVD Clinical Chemistry Analyser Catalog Number: RX5000
- Manufacturer
- Randox Laboratories Ltd.
- Hazard
- incorrect-results
- software-malfunction
Distribution
Distributed nationwide across the United States.
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