Recall Z-1013-2017 ยท GKZ Counter, Differential Cell
Beckman Coulter Inc.
UniCel DxH 800 Coulter Cellular Analysis System, Catalog No. 629029, B24465, B24802, B68304
| Date | Jan 11, 2017 (initiated Dec 19, 2016) |
| Status | Terminated |
| Reason | Beckman Coulter has determined that additional clarification for the Blast Suspect messages is necessary. In rare situations, the UniCel DxH 800 and DxH 600 Coulter Cellular Analysis System may not flag or detect blasts in some blood samples. This is due to limitations in the available technology as well as sample limitations. |
| Root cause | Under Investigation by firm |
| Action | Beckman Coulter sent an Urgent Medical Device Recall letter dated December 19, 2016, to all affected customers to inform them that Beckman Coulter has determined that additional clarification for the Blast Suspect messages is necessary. In rare situations, the UniCel DxH 800 and DxH 600 Coulter Cellular Analysis System may not flag or detect blasts in some blood samples. The letter informs the customers of the impact, actions to be taken, and resolution. Customers are instructed to complete and return the enclosed Response Form within 10 days. Customers with questions are instructed to cont |
| Quantity | 4,657 units total (2,067 units in US) |
| Distribution | Worldwide Distribution - USA (nationwide) Distribution including Puerto Rico and to the countries of : Australia, Belarus, Belgium, Bosnia and Herzegovina, Brunei Darussalam, Canada, China, Columbia, Croatia, Czech Republic, France, Germany, Gibraltar, Ecuador Hong Kong, India, Israel, Italy, Japa |
| 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 |