Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 21694 |
| Brand Name: | Chemistry Analyser Module |
| Model: | |
| Affected: | cobas c501 and cobas c502 chemistry analyser modules. |
| Software version: | |
| Recalling Organisation: | Roche Diagnostics (NZ) Ltd 15 Rakino Way Mt Wellington AUCKLAND 1644 |
| Contact Information: | 0800 363 622 |
| Manufacturer: | Roche Diagnostics GmbH |
| Issue: | A case was reported, in which an operator suffered a blood injury (cut thumb) after attempting to remove the metal cover of the ultrasonic mixer 3 (USM 3). This injury occurred during routine maintenance when the thumb screws holding USM 3 cover were being loosened to remove the USM cover and thus allow access to the waterbath and allow replacement of the cuvettes. Contact between the operator's thumb and the edge of the USM cover caused this injury. |
| Recall action type: | Correction |
| Recall action: | Manufacturer to issue advice regarding use |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 18/7/2017 |
