Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 15774 |
| Brand Name: | Beckman Coulter UniCel DxH 600 & DxH 800 Cellular Analysis Systems |
| Model: | Part Numbers: B23858 & 629029 |
| Affected: | |
| Software version: | |
| Recalling Organisation: | Beckman Coulter NZ Ltd Suite 2, Level 4 30 St Benedicts Street Newton AUCKLAND |
| Contact Information: | 0800 446 109 |
| Manufacturer: | Beckman Coulter Inc |
| Brand Name: | Beckman Coulter DxH Cleaner |
| Model: | Part Numbers: 628022, 628023 |
| Affected: | 12 specific lots |
| Software version: | |
| Recalling Organisation: | Beckman Coulter NZ Ltd Suite 2, Level 4 30 St Benedicts Street Newton AUCKLAND |
| Contact Information: | 0800 446 109 |
| Manufacturer: | Beckman Coulter Inc |
| Issue: | Complaints related to optical degradation have increased on the DXH 800 and DXH 600 Systems. Customers have reported that they are experiencing an increase in one or more of the following: * Flow cell clogs (: : ::) * LS offset errors during Daily Check or control analysis * High coefficients of variation (CV) for Latron CP-X Controls for Low angle Light Scatter (LALS) and/or Axial Light Loss (ALL) parameters * System messages and R-flagged results for NRBC, Diff and Retic during control or patient analysis, such as partial clogs (Low Event Rated with Diff Rs) or a voltage failure (System Event: D with Diff Rs) |
| Recall action type: | Correction |
| Recall action: | Instructions for use to be updated |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 29/11/2013 |
