Recall Z-3101-2017 ยท GKZ Counter, Differential Cell
Beckman Coulter Inc.
UniCel DxH Slidemaker Stainer Coulter Cellular Analysis System, Software Version 3.2. The DxH Slidemaker Stainer allows for adaptation of the smear appearance and stain methodology according to user preferences. Blood smears produced by the Slidemaker portion of the DxH Slidemaker Stainer are moved to baskets for transfer to the Stainer portion by a robot arm. Microscopic examination of the
| Date | Jun 20, 2017 |
| Status | Terminated |
| Reason | The firm has identified that a fitting in some Slidemaker Stainer units may not completely seal after installation. |
| Root cause | Employee error |
| Action | Beckman Coulter sent an Urgent Medical Device Recall letter dated June 20, 2017. The notification advised consignees to immediately contact a Beckman Coulter representative if a leak is observed to schedule a service, to inspect reagent supply drawer for spills, and to follow best laboratory practices when using the device (including Personal Protective Equipment). Beckman Coulter indicates that the issue will be resolved with the replacement of the correct fitting on all impacted instruments. Labs were advised to notify all staff of the recall and to retain the notification. They were also i |
| Quantity | 310 units |
| Distribution | Worldwide Distribution - USA (nationwide) Distribution to the states of : AL, AR, AZ, CA, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, NC, NJ, NV, NY, OH, OR, PA, RI, SC, TN, TX, VA, WA, and WV., and to the countries of : Australia, Brazil, Canada, Chile, China, Czech Republic, |
| 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 |