Recall Z-1197-2019 ยท JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Abbott Gmbh & Co. KG
Abbott Alinity c Processing Module LN 03R67-01 - Product Usage: The Alinity c processing module is a fully automated chemistry analyzer allowing random and continuous access, as well as priority and automated retest processing using photometric and potentiometric detection technology. The Alinity c processing module uses photometric detection technology to measure sample absorbance for the quantif
| Date | Feb 26, 2019 |
| Status | Terminated |
| Reason | The safety interlock covering the septum piercing probes within the bulk solution bottle holder may not deploy when a bulk solution bottle is removed from the Alinity ci series and Alinity s System. |
| Root cause | Under Investigation by firm |
| Action | On February 26, 2019, Abbott sent a correction notice to there customers stating to please continue to follow the instructions provided in the Alinity ci series Operations Manual when replacing the bulk solutions. Use caution when accessing bulk solution bottle holders or replacing bulk solution bottles as you may be exposed to a sharp hazard. The Alinity ciseries Operations Manual will be updated in the future to add the appropriate hazard information to the procedure. If the safety interlock or bottle release does not function correctly, please contact your area customer support for assist |
| Quantity | 559 |
| Distribution | Worldwide distribution - US Nationwide in the states of AR, CA, GA, ME, MN, MO, NY, OK, SC, TN, TX, UT, and VA, and countries of ARGENTINA, AUSTRALIA, AUSTRIA, BAHRAIN, BANGLADESH, BELGIUM, BRAZIL, BULGARIA, CANADA, CHILE, CHINA, COLOMBIA, CROATIA, CZECH REPUBLIC, DENMARK, ESTONIA, FINLAND, FRANCE, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.