FDA: Class I recall of BASE10 Genetics RNAstill MTM specimen collection kits
Editor's Note The Food and Drug Administration (FDA) on February 18 identified the recall by BASE10 Genetics of its RNAstill MTM specimen collection kits as Class I, the most serious. The specimen collection kits are intended for collection, transport, inactivation, stabilization, and long-term storage of nasopharyngeal or oropharyngeal swab samples…
FDA: Class I recall of E25Bio COVID-19 Direct Antigen Rapid Tests
Editor's Note The Food and Drug Administration (FDA) on February 18 identified the recall by E25Bio (Cambridge, Massachusetts) of its COVID-19 Direct Antigen Rapid Tests as Class I, the most serious. The tests are being recalled for several reasons, particularly because they were marketed and distributed in the US without…
FDA: Class I recall of Empowered Diagnostics COVID-19 tests
Editor's Note The Food and Drug Administration (FDA) on January 28 identified the recall by Empowered Diagnostics (Pompano Beach, Florida) of its CovClear COVID-19 Rapid Antigen Test and ImmunoPass COVID-19 Neutralizing Antibody Rapid Test as Class I, the most serious. Empowered Diagnostics distributed these tests with labeling indicating they were…
Medtronic recalls TurboHawk Plus Directional Athrectomy System
Editor's Note On February 7, Medtronic announced that it had issued a voluntary recall of its 6Fr TurboHawk Plus Directional Atherectomy System because of the risk of tip damage caused by guidewire prolapse. To date, there have been no reports of tip damage and no reports of injuries or deaths…
FDA: Update on Class I recall of certain Philips Respironics ventilators, repair kits
Editor's Note The Food and Drug Administration (FDA) on January 26 updated the Class I recall of certain Trilogy Evo ventilators and repair kits for Trilogy Evo muffler assembly, which are manufactured by Philips Respironics. According to the update, the FDA has asked the company to have an independent laboratory…
FDA: Class I recall of Medtronic’s HawkOne Directional Atherectomy System
Editor's Note The Food and Drug Administration (FDA) on January 21 identified the recall by Medtronic Inc of its HawkOne Directional Atherectomy System as Class I, the most serious. The recall was initiated because of the risk of the guidewire within the catheter moving down ward or prolapsing when force…
FDA: Class I recall of Getinge Vaporizer Sevoflurane Maquet Filling for Flow Family Anesthesia Systems
Editor's Note The Food and Drug Administration (FDA) on January 19 identified the recall by Getinge of its Vaporizer Sevoflurane Maquet Filling for Flow Family Anesthesia Systems as Class I, the most serious. The recall was initiated because of the potential chemical breakdown of Sevoflurane that may result in inhalation…
FDA: Class I recall of Medtronic Synergy Cranial, StealthStation S7 cranial software
Editor's Note The Food and Drug Administration (FDA) on January 6 identified the recall by Medtronic of its Stealth Station System with Synergy Cranial and StealthStation S7 Cranial Software as Class I, the most serious. The System aids in precisely locating anatomical structures in neurosurgical procedures. The recall was initiated…
FDA: Class I recall of Cardiovascular Systems’ WIRION Embolic Protection Device
Editor's Note The Food and Drug Administration (FDA), on January 10, identified the recall of Cardiovascular Systems’ WIRION Embolic Protection Device as Class I, the most serious. The device, which is used to hold or remove debris or blood clots from the lower limbs, was recalled because of complaints of…
FDA: Class I recall of Puritan Bennett 980 Series Ventilator
Editor's Note The Food and Drug Administration (FDA), on January 3, identified the recall by Covidien of its Puritan Bennett 980 Series Ventilator as Class I, the most serious. The recall was initiated because of a capacitor manufacturing assembly error that may cause the ventilator to become inoperable or stop…
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