Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 21476 |
| Brand Name: | DxH 500 |
| Model: | |
| Affected: | Software Versions 1.0.2 |
| 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: | The manufacturer has become aware that when the instrument temperature (<18°C to >36.5°C) is exceeded, the DxH 500 allows sample processing and result reporting despite the Instructions for Use stating that The run sample is inaccessible. Results generated in this scenario may be erroneous. Additionally: " The message on the results screen/printout reads Instrument Temperature instead of Instrument Temperature Out of Range. " The results are transmitted to the Laboratory Information System (LIS) without the accompanying Instrument Temperature Out of Range message. Using the auto-transmit option could lead to the release of erroneous results to the LIS. |
| Recall action type: | Correction |
| Recall action: | Software to be upgraded |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 31/5/2017 |
