NEW YORK – The US Food and Drug Administration said in a recent warning letter to UK-based Randox Laboratories that the company had failed to adequately address the risk that several of its analyzers could carry over reagents between tests, adding that those testing systems were out of compliance with manufacturing requirements.
The agency said in a Dec. 6, 2024, warning letter that its concerns relate to Randox's RX Daytona, RX Daytona+, and RX Imola test systems. The company had inadequate procedures for validating device designs, and the FDA noted that the firm had issued five Class II recalls for its RX-series analyzers since 2018 because assay reagents had carried over to subsequent tests and caused erroneous results.
A Class II recall is used to address issues that have a risk of temporary or medically reversible adverse health consequences but that have little danger of serious adverse health consequences.
In one instance, a customer reported in October 2023 that reagents from a total protein test performed on an RX Daytona+ analyzer had carried over to a copper assay, which resulted in falsely elevated copper results. That carryover was attributed to inadequate cleaning of cuvettes and pipettes on the automated analyzer, although the underlying cause was not identified. The FDA also said in the warning letter that the firm had not identified what corrective and preventive actions it has taken or how it will show they are effective.
From February 2018 through November 2023, Randox issued and updated a technical bulletin with a list that has grown to contain more than 50 combinations of assays to avoid running in sequence to avoid reagent carryover. However, the firm had not identified the control measures that could reduce the risks of reagent carryover or the actions that could be taken to correct those issues.
The FDA also said that the company has not yet sent certain documents related to risk analysis and management.
The agency requested that Randox, within 15 business days of receipt of the warning, explain how the company plans to prevent additional violations and document any corrections or corrective actions.