Recall Z-2157-2017 ยท GKZ Counter, Differential Cell
Beckman Coulter Inc.
UniCel DxH 800 Coulter Cellular Analysis System, Catalog No. 629029, B24465, B24802, B66445, B68304, B63322.
| Date | Apr 24, 2017 |
| Status | Terminated |
| Reason | There is a possibility of a data acquisition disruption that may cause an unusual light scatter event pattern for the white blood cell differential that may not have a system flag and/or message. The events associated with the unusual light scatter pattern may be incorrectly removed from analysis which can result in an erroneous differential result. |
| Root cause | Device Design |
| Action | An Urgent Medical Device Recall letter dated 4/24/17 was sent to customers to inform them that there is a possibility of a data acquisition disruption that may cause an unusual light scatter event pattern for the white blood cell differential that may not have a system flag and/or message. The events associated with the unusual light scatter pattern may be incorrectly removed from analysis which can result in an erroneous differential result. The letter informs the customers of the issue, impact, action, and resolution. Customers are instructed to complete and return the enclosed response for |
| Quantity | 4880 units total (2119 units in US) |
| Distribution | Worldwide distribution: US nationwide, Algeria, Andorra, Austria, Australia, Belarus, Belgium, Bosnia and Herzegovina, Brazil, Brunei Darussalam, Bulgaria, Canada, China, Colombia, Costa Rica, Cote d'lvoire, Croatia, Czech Republic, Ecuador, France, Germany, Gibraltar, Greece, Hong Kong, Hungary, I |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K081930 | UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM Beckman Coulter, Inc., Dec 19, 2008 |
| K120771 | UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM Beckman Coulter, Inc., Mar 22, 2013 |
| K140911 | UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM/ UNICEL DXH SLIDEMAKER STAINER COULTER CELLULAR ANALYSIS SYSTEM Beckman Coulter, Inc., Sep 5, 2014 |