Recall Z-1316-2019 ยท JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Abbott Gmbh & Co. KG
Abbott Alinity ci-series System Control Module software version 2.5.1; LN 3R70-01 with the following hardware: Level Sensor, Bulk Solution; 04S68-01, Accessory Kit, Alinity I; 03R66-01and 03R66-02 , and Accessory Kit, Alinity c; 03R69-01 and 03R69-02. Product Usage: The Alinity i (LN 03R65 01) processing module is a fully automated immunoassay analyzer allowing random and continuous access, a
| Date | Mar 7, 2019 |
| Status | Terminated |
| Reason | Potential performance issues in the Alinity-ci software version 2.5.1 |
| Root cause | Under Investigation by firm |
| Action | On March 7, 2019 Abbott issued the attached Product Correction letters to all installed Alinity ci series instrument customers: 1. Softwarerelated actions: Your Abbott representative will schedule a mandatory upgrade of your Alinity ciseries to software version 2.6.0 to resolve each of these issues. Refer to Appendix A for necessary actions required until software version 2.6.0 can be installed. Software version 2.6.0 also provides enhancements and additional changes to increase the usability of your system. If you require additional information, please contact Abbott Customer Service. 2. Th |
| Quantity | 1557 |
| Distribution | AR, AZ, CA, FL, GA, IL, MA, ME, MN, MO, NY, OK, SC, TN, TX, UT, VA, WI, and Puerto Rico ALGERIA, ARGENTINA, AUSTRALIA, AUSTRIA, BAHRAIN, BANGLADESH, BELGIUM, BOSNIA AND HERZEGOVINA, BRAZIL, BULGARIA, CANADA, CHILE, CHINA, COLOMBIA, CROATIA, CZECH REPUBLIC, DENMARK, ESTONIA, FINLAND, FRANCE, GERMANY |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.