Recall Z-2732-2016 ยท GKZ Counter, Differential Cell
Beckman Coulter Inc.
UniCel DxH 800 and DxH 600 Coulter Cellular Analysis System. Catalog No. 629029, B24465, B24802, B68304 (Unicel DxH 800 Coulter Cellular Analysis System). Catalog No. B23858 (Unicel DxH600 Coulter Cellular Analysis System).
| Date | Sep 2, 2016 (initiated Aug 8, 2016) |
| Status | Terminated |
| Reason | There is a possibility of specimen misidentification for the stand-alone DxH 800 and DxH 600 where the Primary Identifier is configured to Tube Position ID. |
| Root cause | Software design |
| Action | An Urgent Medical Device Recall letter dated 8/8/16 was sent to all customers who purchased the Unicel DxH 800 and DxH 600 Coulter Cellular Analysis System to inform them that there is a possibility of specimen misidentification for the stand-alone DxH 800 and DxH 600 where the Primary Identifier is configured to Tube Position ID. Customers are instructed to complete and return the enclosed response form within 10 days. Customers with any questions regarding the notice are instructed to contact Customer Support Center: http://www.beckmancoulter.com/customersupport/support; 800-526-7694 in t |
| Quantity | 5,282 units total (2,877 units in US) |
| Distribution | Affected geographies: Andorra, Australia, Belarus, Belgium, Bosnia and Herzegovina, Brunei Darussalam, Canada, China, Columbia, Croatia, Czech Republic, Egypt, Ecuador, France, Germany, Gibraltar, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Korea, Kuwait, Le |
| 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 |