Recall Z-2201-2019 ยท JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Abbott Gmbh & Co. KG
The Alinity ci-series System Control Modules which are configured with Alinity c Processing Modules. The Alinity ci-series Control Module is labeled in part,"* * *Alinity ci-series* * *SYSTEM CONTROL MODULE Product Usage: The Alinity ci series System Control Module has a scalable design to provide full integration of clinical chemistry and immunoassay analysis. The Alinity ci series System Contro
| Date | May 21, 2019 |
| Status | Terminated |
| Reason | All versions of the Alinity ci-series software may not detect an issue on the Alinity c Integrated Chip Technology (ICT) assays, sodium (Na+), potassium (K+), and chloride (Cl-). |
| Root cause | Under Investigation by firm |
| Action | On May 21, 2019, the firm sent Product Correction Urgent - Immediate Action Required letters to all of their consignees which advised them of the problem and provided them with instructions for preforming additional testing. US customers were sent this letter and an attached Customer Reply Immediate Action Required form vis FedEx priority overnight express. Abbott service personnel will follow-up to install new software. |
| Quantity | 943 systems |
| Distribution | Worldwide Distribution - US Nationwide AL, AR, CA,, FL, GA, ID, IL, LA, MA, ME, MI, MN, MO, NJ, NY, OK, SC, TN, TX, UT, VA, WA, WI, and PUERTO RICO. ALBANIA, ALGERIA, ARGENTINA, AUSTRALIA, AUSTRIA, BANGLADESH, BELGIUM,BOTSWANA, BRAZIL, BULGARIA, CANADA, CHILE, CHINA, COLUMBIA, CROTIA, CZECH REPUBLIC |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.