CDRH New Update

The following new items were added to the CDRH web pages on November 1, 2018. Previous CDRH New items can be found on the CDRH New webpage. Press Release: FDA warns patients and doctors about risk of inaccurate results from home-use device to monitor blood thinner warfarin Class I Recall: Roche Diagnostics Recalls CoaguChek XS PT Test Strips Due to Inaccurate INR Test Results Class I Recall: Maquet Datascope Corp./Getinge Group Recalls the Cardiosave Hybrid and Cardiosave Rescue Intra-Aortic Balloon Pumps (IABPs) Due to Possible Malfunction and Failure at High Altitudes Device Failure Associated with Getinge's Maquet/Datascope Intra-Aortic Balloon Pumps - Letter to Health Care Providers The FDA Warns Against the use of Many Genetic Tests with Unapproved Claims to Predict Patient Response to Specific Medications: FDA Safety Communication Direct-to-Consumer Tests Federal Register: Medical Devices Rule: Clinical Chemistry and Clinical Toxicology Devices; Classification of the Insulin Therapy Adjustment Device Federal Register: Medical Devices Rule: Clinical Chemistry and Clinical Toxicology Devices; Classification of the Meprobamate Test System Federal Register: Laser Products Proposed Rule: Performance Standard and the Electronic Submission of Labeling for Certain Home-Use Medical Devices; Withdrawal