Radiometer America Inc - Radiometer, ABL 80, ABL90, ABL 800 FLEX Blood Gas analyzers with AQURE Software version 2.2.0 - Class 2 Recall
AQURE System Software Version 2.2.0 Model #: 933-599 UDI: (01)05700699335999(10)2.2.0 Catalog number: 933-599 The AQURE system manages Radiometer blood gas and immunoassay analyzers and results from 3rd party devices for point of care testing placed throughout the hospital. It enables the user to track connected devices, monitor performance and availability, and to quickly resolve and document issues (including allowing the customer to track root cause and corrective action taken). Intended use: The AQURE system is intended to let you manage analytical devices and operator profiles. The user can associate patient data wi...
Source: Medical Device Recalls - December 23, 2016 Category: Medical Equipment Source Type: alerts
Beckman Coulter Inc. - MicroScan LabPro Data Management System - Class 2 Recall
MicroScan LabPro Data Management System. Intended to manage both microbial identification (ID) and antimicrobial agent susceptibility testing (AST) data generated from MicroScan instruments or manually entered microbiology test results, for use by trained laboratory personnel. (Source: Medical Device Recalls)
Source: Medical Device Recalls - December 16, 2016 Category: Medical Equipment Source Type: alerts
Roche Molecular Systems, Inc. - Class 2 Recall
LightMix¿ Zika rRT-PCR Test The LightMix¿ Zika rRT-PCR Test is a real-time RT-PCR test intended for the qualitative detection of RNA from the Zika virus in serum or EDTA plasma from individuals meeting CDC Zika virus clinical criteria (e.g., clinical signs and symptoms associated with Zika virus infection) and/or CDC Zika virus epidemiological criteria (e.g., history of residence in or travel to a geographic region with active Zika transmission at the time of travel, or other epidemiologic criteria for which Zika virus testing may be indicated). Testing is limited to laboratories certified under the Clinical Labo...
Source: Medical Device Recalls - December 14, 2016 Category: Medical Equipment Source Type: alerts
Diasorin Inc. - DiaSorin LIAISON Estradiol II Gen assay - Class 2 Recall
LIAISON Estradiol II Gen, 310680, 310680-CN The DiaSorin LIAISON Estradiol II Gen assay is a chemiluminescent immunoassay (CLIA) intended for the quantitative determination of estradiol in human serum. Assay results should be used in conjunction with other clinical and laboratory data to assist in the diagnosis and management of conditions involving an excess or deficiency of estradiol. The test has to be performed on the LIAISON Analyzer Family. (Source: Medical Device Recalls)
Source: Medical Device Recalls - November 22, 2016 Category: Medical Equipment Source Type: alerts
Inpeco S.A. - Inpeco SA FlexLab, Accelerator a3600 and Aptio Automation - Class 2 Recall
FlexLab, Accelerator a3600 and Aptio Automation are modular systems designed to automate Pre-Analytical and Post-Analytical processing, sample handling in order to automate sample processing in the Laboratory. The systems consolidate multiple Analytical instruments into a unified workstation. (Source: Medical Device Recalls)
Source: Medical Device Recalls - November 17, 2016 Category: Medical Equipment Source Type: alerts
