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Regulatory Focus™ > News Articles > 2019 > 8 > FDA Designates QIAGEN Recall, Centurion Recall

FDA Designates QIAGEN Recall, Centurion Recall

Posted 02 August 2019 | By Ana Mulero 

FDA Designates QIAGEN Recall, Centurion Recall

The US Food and Drug Administration (FDA) classified on Friday a QIAGEN recall of filter-tips used with two QIAGEN assays indicated for monitoring treatment of a common virus and evaluating blood cancers, as well as a Centurion Medical Products recall of airways kits containing Teleflex endotracheal tubes and connectors. 

Following a 5 June correction letter that QIAGEN sent to its laboratory customers, the agency is now identifying QIAGEN's recall as Class I. The recall affects a total of 1,269,760 filter-tips in 1,240 kits in the US. The QIAGEN artus CMV QS-RGQ MDx for monitoring antiviral treatment of cytomegalovirus and the QIAGEN ipsogen JAK2 RGQ PCR for evaluating patients for myeloproliferative neoplasms both use the filter-tips.

The QIAGEN recall comes as a result of a manufacturing malfunction that caused internal abrasions in defective filter-tips from “a bent manufacturing pin,” according to FDA. “The affected QIAGEN filter-tips have the potential to leak, which may result in delayed or inaccurate results.” The agency adds that QIAGEN customers report splashes on the QIAsymphony instrument, liquid in the tip guard, dripping/leaking tips, failed test signals, empty wells indicative of volume loss, and incorrect test results with use of the defective tips.”

FDA further notes that the issue can have severe consequences on patient health if incorrect results go undetected, though the risks depend on the test that is being performed and the importance of the test results to support clinical diagnosis. QIAGEN has reportedly received three complaints from US clients.

QIAGEN and FDA list recommendations for customers which include ceasing use of affected filter-tips.

Centurion is recalling 80 airway kits containing certain Sheridan endotracheal tubes and connectors, previously recalled by manufacturer Teleflex, and 70 components in the US. FDA identifies this recall as Class I, also.

Centurion’s recall is due to adverse event reports of Teleflex’s products that describe several incidences of the firm's tube connector dislodging from the endotracheal tube. FDA says “four deaths and 18 injuries have been reported to Teleflex in association with disconnection. Yet Centurion has “no reported injuries or complaints."

FDA cites a notification letter Centurion sent to its parent company and only customer for the affected products, Medline, last month. The letter instructs Medline to return the affected products. The Centurion products affected by this recall include the Kit TC7855 and Component TTCONG0 model numbers, according to FDA. 

QIAGEN, Centurion Medical Products

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