UNITED STATES – According to an online news article published by www.raps.org, the FDA has recently designated two medical device recalls involving QIAGEN and Centurion as Class I, the most serious designation available.
The United States Food and Drug Administration (FDA) regulates the sale and use of medical devices. When manufacturers recall a product, the FDA will classify the recall based on the reason for the recall, and the potentially dangerous consequences of using the product. The FDA only designates recalls as Class I when the product subject to recall has the potential to cause serious injuries or death.
QIAGEN Recalls Filter-Tips
QIAGEN recently recalled filter-tips that are used with two QIAGEN assays indicated for monitoring the treatment of a common virus as well as evaluating blood cancers. QIAGEN’s recall affects 1,269,760 filter tips that were used with a total of 1,240 kits in the United States.
The kits that use the filter tips include the (1) QIAGEN artus CMV QS-RGQ MDx indicated for monitoring antiviral treatment of cytomegalovirus, and (2) QIAGEN ipsogen JAK2 RGQ PCR for evaluating patients for myeloproliferative neoplasms.
QIAGEN issued the recall of more than 1.2 million filter-tips after learning of a manufacturing malfunction that caused internal abrasions to the tips, leading the tips to potentially leak. Leaking tips can lead to delayed or inaccurate test results, which can be dangerous to patients. If a patient’s test results are delayed or inaccurate, the patient is at risk of suffering harm.
Centurion Medical Products Recalls Airway Kits
Centurion manufactures airway kits that contain certain Sheridan endotracheal tubes and connectors manufactured by Teleflex. Centurion has recalled the airway kits following adverse event reports regarding Teleflex endotracheal tubes and connectors.
The FDA states that there have been 4 deaths and 18 injuries associated with disconnection of Teleflex endotracheal tubes and connectors. Centurion has no reported injuries or complaints associated with its airway kits. The company has recalled a total of 80 airway kits and 70 components not in kits.
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