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FDA Issues Notice on Qiagen Recall of QiaSymphony MDx Platform Filter Tips

NEW YORK – Qiagen has issued a recall in the US for filter tips used with its QiaSymphony SP/AS (sample prep/assay setup) instruments, due to potential leaking issues that may lead to delayed or inaccurate results, the US Food and Drug Administration said in a safety bulletin issued late Friday afternoon.

The Class I recall is the most serious type, indicating that using the potentially faulty devices may cause serious injuries or death.

The recall applies specifically to lot numbers 0605020019 and 0605020020, which cover 1500-μl filter tips for use with the QiaSymphony SP/AS instruments manufactured between Sept. 7, 2018 and Sept. 18, 2018, and distributed from Feb. 11, 2019 to March 9, 2019. Qiagen initiated the recall on June 5, issuing a correction letter to its US laboratory customers. The recall affects more than 1.2 million tips in 1,240 kits in the US.

There are two FDA-approved assays for use with the filter tips on the QiaSymphony platform: the Qiagen Artus CMV QS-RGQ MDx for quantifying cytomegalovirus in blood to monitor antiviral treatment; and the Qiagen Ipsogen JAK2 RGQ PCR to aid in the evaluation of patients with myeloproliferative neoplasms.

The filter tips are also used on the QiaSymphony platform for laboratory-developed tests and as part of other clinical workflows, including genetic testing, oncology testing, or research, the FDA noted.

The QiaSymphony SP module enables sample preparation of DNA, RNA, and bacterial and viral nucleic acids from a wide range of starting materials, Qiagen notes on its website. The AS module extends the capabilities of the SP by integrating automated PCR assay setup.

"Due to a manufacturing malfunction resulting in defective filter tips having internal abrasions from a bent manufacturing pin, the affected Qiagen filter tips have the potential to leak, which may result in delayed or inaccurate results, including false positive results, false negative results, or incorrect quantification," the FDA said.

The company received three complaints from US customers, but no injuries or deaths have been reported from inaccurate test results.

The FDA noted that affected parties may include laboratory personnel who used QiaSymphony SP/AS instruments with affected tips from Feb. 11, 2019 to June 5, 2019; or patients who had specimens tested using instruments with affected tips in that same time period.