Recall Z-2701-2020 ยท JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Abbott Gmbh & Co. KG
Alinity ci series System Control Module (SCM); LN 3R70-01 Alinity ci series software versions, 3.1.1 and below
| Date | Jun 19, 2020 |
| Status | Terminated |
| Reason | Quality Control results were not properly evaluated for QC failures. |
| Root cause | Under Investigation by firm |
| Action | On June 19, 2020, Abbott issued Product Correction letters to all installed Alinity ciseries instrument customers: customers were asked to do the following action: 1. Your Abbott representative will schedule a mandatory upgrade of your Alinity ciseries to software version 3.2.0. Until software version 3.2.0 is installed on your Alinity ciseries, Abbott recommends the following workarounds for issues 1 and 2: 2. In order to restore the QC analysis function for all assay files that have been previously updated and for all future assay file revisions until software 3.2.0 is installed on your s |
| Quantity | 3166 |
| Distribution | Worldwide distribution - US Nationwide distribution and the countries of ALBANIA, ALGERIA, ARGENTINA, AUSTRALIA, AUSTRIA, BAHRAIN, BANGLADESH, BELGIUM, BERMUDA, BOSNIA AND HERZEGOVINA, BOTSWANA, BRAZIL, BULGARIA, BURKINA FASO, CANADA, CHILE, CHINA, COLOMBIA, COSTA RICA, CROATIA, CZECH REPUBLIC, DENM |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.