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Qiagen Recalls Software for Rotor-Gene Q PCR Platform

NEW YORK – Qiagen has issued a recall of software used with its Rotor-Gene Q (RGQ) real-time PCR system because of a glitch in its data reporting function that could cause false-negative results from PCR assays running on the instrument.

The recall, which Qiagen initiated on Jan. 28, was posted to the US Food and Drug Administration website on Thursday. It is a class II recall, meaning that the underlying issue could cause serious injury or temporary illness in patients.

The recall specifically pertains to the Qiagen RGQ software version 2.3.4. According to the recall notice, when this software completes an export of data to a laboratory information management system (LIMS), the comma-separate values (.cmv) file "reports the calculated concentration result value as a logarithmic value, and could lead to a false-negative result, which could lead to serious medical consequences such as the suspension or non-initiation of treatment."

Qiagen issued an urgent medical device correction via email to customers on Jan. 28, advising them to discontinue use of the instrument if it is running the specified software using the export function to a LIMS. The company also advised users to upgrade to the latest version of the RGQ software (2.3.5), which became available in early February.

"Laboratory personnel and clinicians are advised to consider a patient’s previous test results, other diagnostic tests, anamnesis, and current clinical condition when interpreting results from this software," the recall notice states. "If the results do not match the patient's clinical presentation, or incongruences are found with previous and concomitant tests or the results are otherwise unexpected, the patient sample should be retested using an alternate test method or a reference laboratory."

The recall applies to a number of versions of the RGQ platform and can affect several different Qiagen IVD kits that typically run on the system, including tests for BK virus, cytomegalovirus, Epstein-Barr virus, hepatitis B and C viruses, HIV-1, Varicella-Zoster virus, JCV, Mycobacterium tuberculosis, parvovirus B19, and SARS virus.

In an email, Qiagen spokesperson Thomas Theuringer said that Qiagen issued the notification after being made aware of the issue by a single customer in Japan, and that no other customers have since reported the problem.

"Qiagen does not believe that most customers use the LIMS export function, but for reasons of caution we decided to inform all RGQ customers and offer them a corrected software, which was made available as a download in February on the Qiagen website," he added. "The update can be easily downloaded and installed by any customer."

The Rotor-Gene Q platform has also been identified by the FDA as a suitable instrument for performing the US Centers for Disease Control’s Emergency Use Authorized test for SARS-CoV-2, the novel coronavirus causing the global COVID-19 pandemic. However, Theuringer pointed out, there are currently no IVD assays for SARS-CoV-2 on the market. "Potentially labs could create LDTs, although it is not likely that these assays would be quantitative and use the LIMS export function," Theuringer said. An FDA spokesperson later confirmed this.