UNITED STATES – As reported in an online news article published by www.raps.org, the FDA has categorized recent QIAGEN and Centurion medical device recalls as Class I, notifying patients and healthcare providers about the potential dangers associated with the affected medical devices.
The United States Food and Drug Administration (FDA) routinely classifies recalls based on how serious they are in terms of potential harm to patients. The FDA recently classified 2 medical device recalls as Class I, which means that the medical devices pose a risk of serious injury or death to patients. The first recall involves QIAGEN filter-tips while the other involves Centurion airway kits.
QIAGEN issued a recall of its filter-tips which are used with two QIAGEN assays to monitor treatment of common viruses and to evaluate blood cancers. A total of 1,269,760 filter-tips are subject to the Class I recall, and these filter-tips were used with a total of 1,240 kits within the United States. Such kits include the QIAGEN artus CMV QS-RGQ MDx indicated for monitoring antiviral treatment of cytomegalovirus, and the QIAGEN ipsogen JAK2 RGQ PCR for evaluating patients for myeloproliferative neoplasms.
The reason QIAGEN recalled well over 1.2 million filter-tips was because of a manufacturing malfunction which led to internal abrasions on the tips and potential leaking. Such leaking may result in delayed or inaccurate test results, posing a risk of harm to patients. Healthcare providers rely on accurate test results to plan their patients’ care. As such, delayed or inaccurate test results could be very dangerous for patients.
Centurion Medical Products Airway Kits
Many medical devices are comprised of components designed and manufactured by more than one company. Centurion Medical Products designs and manufactures airway kits that are used in conjunction with certain Sheridan endotracheal tubes and connectors manufactured by Teleflex.
There have been numerous adverse event reports related to the Teleflex connectors. According to the FDA, there have been 4 reported deaths and 18 reported injuries associated with the disconnection of the Teleflex endotracheal tubes and connectors. While Centurion has not received any reports of injuries or deaths, the company is recalling its airway kits to ensure there is no additional risk to patients. Centurion recalled 80 airway kits and 70 standalone components that are not part of any kit.
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