Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 23442 |
| Brand Name: | UniCel DxH 800 Coulter Cellular Analysis System |
| Model: | 3.2.0 and below, 1.3.0 and below |
| 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 Australia Pty Ltd |
| Issue: | This notification is an update to the previous urgent Product Correction Notice dated July 30, 2018 concerning sporadic erroneously elevated platelet results. The manufacturer has confirmed complaints of erroneously elevated platelet results with rare occurrences, without flags or system messages. The underlying issue is temporary disturbance of the sweep flow. Preliminary root cause investigation indicates that sweep flow disruption may occur following the Clear RBC Apertures procedure. The issue may affect one or multiple samples tested in sequence. |
| Recall action type: | Recall |
| Recall action: | Software to be upgraded |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 28/5/2019 |
