Company: Roche Diagnostics Operations, Inc. Date of Enforcement Report: 8/11/2022 Class II PRODUCT cobas e801 Immunoassay Analyzer Recall Number: Z-1515-2022 REASON Software issue resulting in signals and sample test results of Pre-Wash tests being impacted. The following assays are considered impacted by the issue: Anti-HAV2, Anti-HBc IgM, IGF-1, Myogloin, Rubella IgG, and Toxo IgG. RECALLING...Read More

Company: Spacelabs Healthcare, Inc. Date of Enforcement Report: 8/11/2022 CLASS: II PRODUCT Xhibit Telemetry Receiver, Model: 96280 Recall Number: Z-1513-2022 REASON Software related alarm escalation defect occurs after approximately 25 days of continuous use. Technical alarm escalation for the following alarms, signal loss, all leads off, low battery, SpO2 sensor off, and signal interference, does...Read More