Recall Z-0543-2020 ยท JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Abbott Gmbh & Co. KG
Alinity ci Level Sensor, Bulk Solution
| Date | Sep 16, 2019 |
| Status | Open, Classified |
| Reason | Potential reliability issue with the Alinity ci series Level Sensor, Bulk Solution. The development of environmental stress on the bulk solution level sensor can cause cracks. |
| Root cause | Device Design |
| Action | Abbott GmbH & Co. KG notified customers on about 09/16/2019, via "Product Correction Urgent Immediate Action Required" letter. Customers were informed that the development of environmental stress on the bulk solution level sensor can cause cracks. Cracks can allow air to enter the fluid line, which may result either a failure to dispense or an incomplete dispense of the bulk solution on Alinity i and Alinity c. Instructions included that if using Alinity i, and you receive one of the following message codes: 1043, 1044, 1072, 1402, 1403. Refer to Appendix B in the letter. If using Alinit |
| Quantity | 8,714 units |
| Distribution | Nationwide distribution to AL, AR, AZ, CA, CO, FL, GA, ID, IL, IN, KS, LA, MA, ME, MI, MN, MO, MS, NC, NJ, NV, NY, OK, PR, SC, SD, TN, TX, UT, VA, WA, WI. International distribution to ALBANIA, ALGERIA, ARGENTINA, AUSTRALIA, AUSTRIA, BAHRAIN, BANGLADESH, BELGIUM, BOSNIA AND HERZEGOVINA, BOTSWANA, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.