FDA Says Magellan Diagnostics LeadCare Testing Recall is Class I
Magellan Diagnostics Lead Tests Recalled Due to Inaccurate Results The U.S. Food and Drug Administration (FDA) has placed its most-serious Class I label on Magellan Diagnostics’ recall of LeadCare testing systems. The products are being recalled because they may give inaccurately low results. Failure to identify high levels of lead … [Read more...]
Pocket System Controller Recall
Parker Waichman LLP is investigating potential lawsuits involving the HeartMate Left Ventricular Assist (LVAS) Pocket System Controller. The HeartMate II LVAS is a device that helps pump blood throughout the body when the heart is too weak to do it on its own. The HeartMate II LVAS pump comes with a controller and patients are also … [Read more...]
Class 1 Herpes Test Kits Recalled due to Inaccurate Results
Herpes Test Kits Face Dilemma. Herpes is a highly contagious chronic condition caused by a virus. Many individuals never experience symptoms even though they carry the virus. The HSV1 is oral herpes and symptoms generally include cold sores or blisters. It can be spread through kissing or sharing toothbrushes or eating utensils, … [Read more...]
Recently Approved Medtronic Heart Valve Device under Class 1 Recall
Recall of the EnVeo R loading system has been designated a Class 1 recall. A component Medtronic's CoreValve Evolut R heart valve device is under Class 1 recall less than two months after receiving Food and Drug Administration (FDA) approval. The recall of the EnVeo R loading system has been designated a Class 1 recall, which is … [Read more...]
FDA Announces Class 1 Recall Baxter Infusion Pumps
Class 1 Recall Baxter Infusion Pumps. The U.S. Food and Drug Administration (FDA) and Baxter Healthcare Corporation have notified healthcare professionals regarding the class 1 recall of all models of Colleague and Colleague CX volumetric infusion pumps. The electronic devices are subject to multiple malfunctions that can delay or … [Read more...]
Class 1 Recall: Tosoh Bioscience AIA-600 II Analyzers
Analyzer, with software version 3.02, produced occurrence of false positive and false negative. The FDA first learned of this problem during an inspection of the firm during August - September 2004. Product: … [Read more...]
