Recall Z-0237-2018 ยท GKZ Counter, Differential Cell
Beckman Coulter Inc.
UniCel DxH600, Part Number B23858, automated hematology analyzer (Note: the DxH 600 is the same instrument as the DxH 800 except that it is a bench top unit with no instrument cart, computer stand, and no connectivity capabilities)
| Date | Nov 3, 2017 |
| Status | Terminated |
| Reason | The shield for the Single-Tube Station on the DxH instrument may interfere with sample aspiration in the open vial position. |
| Root cause | Device Design |
| Action | The firm notified its consignees of the recall on 11/03/2017 by letter. The letter stated the issue and provided the following instructions: "To avoid a biohazardous spill, do not use the right (green) position of the Single-Tube Station for sample aspiration until the shield is removed. You may remove the shield following the instructions in Attachment 1 or contact your local Beckman Coulter Representative for further assistance." |
| Quantity | 1 unit |
| Distribution | CA, AR, HI, CA, OH, WA, MD, Canada, Japan |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K140911 | UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM/ UNICEL DXH SLIDEMAKER STAINER COULTER CELLULAR ANALYSIS SYSTEM Beckman Coulter, Inc., Sep 5, 2014 |