Tag: Device recall
FDA: Class I recall of Medtronic Cobalt/Crome ICDs, CRT-Ds
Editor's Note The Food and Drug Administration (FDA) on August 19 identified the recall by Medtronic of its Cobalt XT, Cobalt, and Crome Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) as Class I, the most serious. The devices are being recalled because of reports of short circuit-protection…
FDA: Class I recall of certain Accula SARS-CoV-2 Tests
Editor's Note The Food and Drug Administration (FDA) on May 9 identified the recall by Mesa Biotech, Inc, of certain Accula SARS-CoV-2 Tests as Class I, the most serious. The recall was initiated because certain lots of the PCR test have an increased risk of giving false positive results because…
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