![]() ![]() System (SN:704534-C software version JAMS 137A/CLEW. If the software has not yet been updated to version JAMS 144 / CLEW A35, please follow the directions on the Abbott Point of Care website (see link below) for the installation of the software. validated the i-STAT system for Hct and haemoglobin (Hb) concentration (among other analytes) in. Due to the fact that Quality Check Code 149 requires the test to be repeated, this issue has the potential to delay generation of i-STAT Total ß-hCG results.Ībbott is advising facilities performing testing with i-STAT Total ß-hCG cartridges, to verify that all i-STAT analysers performing i-STAT Total ß-hCG testing have been updated to software version JAMS 144 / CLEW A35. There is no impact on user/patient safety. ![]() Through a combination of internal studies and customer reports, Abbott Point of Care has determined that users may experience an increased frequency of Quality Check Code 149 when testing i-STAT Total ß-hCG cartridges with i-STAT 1 Analyser software version JAMS 143 / CLEW A34. (Abbott Australasia Pty Ltd (Point-of-Care Division) - Clinical chemistry hormone IVDs)Ībbott Australasia Pty Ltd Point-of-Care Division Please follow this 12 step guide to upgrade the CLEW software on your i-STAT. An in vitro diagnostic medical device (IVD) This process is noted in the diagram below Gather equipment for JammLite Utility Connect/set up equipment Load JAMS/CLEW Update i-stat 1 analyzer Verify. For i-STAT test cartridge information and intended use, refer to individual product pages or the cartridge information (CTI/IFU) in the i-STAT Support area. You can download a raw copy of the database here.I-STAT 1 Analyser Software with i-STAT Total â-hCG Cartridge with software version JAMS 143/CLEW A34. Always cite the International Consortium of Investigative Journalists when using this data. The International Medical Devices Database is licensed under the Open Database License and its contents under Creative Commons Attribution-ShareAlike license. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them. Every 6 months the iSTAT Alinity requires a software update, each software update contains 2 elements in a single package: CLEW software and application. New CLEW software - delivered twice a year - re-establishes these. If the software has not yet been updated to version JAMS 144 / CLEW A35, please follow the directions on the Abbott Point of Care website (see link below) for. An in vitro diagnostic medical device (IVD). The same device may have different names in different countries. i-STAT TECHNICAL BULLETIN NETWORK OPTIONS FOR UPDATING THE i-STAT 1 HANDHELD USING. Recall of i-STAT 1 Analyser Software with i-STAT Total -hCG Cartridge with software version JAMS 143/CLEW A34. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. Medical devices help to diagnose, prevent and treat many injuries and diseases. Explore more than 120,000 Recalls, Safety Alerts and Field Safety Notices of medical devices and their connections with their manufacturers.ĭo you work in the medical industry? Or have experience with a medical device? Our reporting is not done yet.
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