Recall Z-1580-2020 ยท JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Abbott Gmbh & Co. KG
LN 3R70-01; software version 2.6.2 and earlier. The software is used with the Alinity i (LN 03R65-01) processing module and the Alinity c (LN 03R67-01) processing module.
| Date | Jan 24, 2020 |
| Status | Terminated |
| Reason | Abbott has identified potential performance issues for the Alinity ci -series Software version 2.6.2 and earlier. |
| Root cause | Software design |
| Action | The firm initiated the recall letter on January 24, 2020. The "Product Correction, Urgent - Immediate Action Required" notice identified the correction of the Alinity ci-series Software version 2.6.2 and earlier due to potential performance issues. the notice informed that Abbott is releasing Alinity ci-series Software version 3.1.0 to correct the issues. The notice provided the necessary actions required to be performed until the mandatory upgrade to SW 3.1.0 is complete. The notice referenced that details are included in table1 below. the notice detail that an Abbott representative will |
| Quantity | 2676 units |
| Distribution | Worldwide distribution - US Nationwide distribution in the states of AL, AR, AZ, CA, CO, FL, GA, ID, IL, LA, MA, MD, ME, MI, MN, MC, MS, NC, NJ, NY, OK, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV and countries of Albania, Argentina, Australia, Austria, Bahrain, Bangledesh, Belgium, Bermuda, Bosnia, Bots |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.