Recall Z-0863-2010 ยท JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Beckman Coulter Inc.
Beckman Coulter UniCel DxC Synchron Clinical System ISE Flow Cell. PN Numbers: A10405 (UniCel DxC 600); A11810 (UniCel DxC 600 PRO); A27318 (UniCel DxC 600i); A11816 (UniCel DxC 800); A11812 (UniCel DxC 800 PRO); A59102 (UniCel DxC 880i); A64903 (UniCel DxC 680i); A64871 (UniCel DxC 660i); A64871 (UniCel DxC 860i). Intended for the in vitro determination of a variety of general chemistries, thera
| Date | Mar 4, 2010 (initiated Jan 4, 2010) |
| Status | Terminated |
| Reason | Excessive Buildup of protein, bacteria and sample tube additives in the ISE flow cell may cause erroneous NA (sodium) results. |
| Root cause | Device Design |
| Action | An Urgent: Product Corrective Action letter dated January 4, 2010, was mailed to customers advising of erroneous sodium results derived from build up of protein, bacteria and additives in the ISE flow cell. The letter discussed the impact and actions to be taken along with some additional recommendations. Customers are advised to follow the new maintenance instructions included with the letter. The information in the letter should be shared with laboratory staff and the notification should be retained as part of the Quality System documentation. A copy of the letter should be provided to a |
| Quantity | 2630 |
| Distribution | Worldwide Distribution -- USA and Canada. |
| FDA record | Open on fda.gov |