Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 16404 |
| Brand Name: | Roche cobas c502 c-pack MULTI |
| Model: | C501 |
| Affected: | |
| Software version: | |
| Recalling Organisation: | Roche Diagnostics (NZ) Ltd 15 Rakino Way Mt Wellington AUCKLAND 1644 |
| Contact Information: | 0800 363 622 |
| Manufacturer: | |
| Issue: | The manufacturer advises there is potential for erroneous results to be generated by the cobas c502 as a consequence of incorrect cassette filling. Due to an in-house labelling software limitation, the ICVC 'on' settings are not correctly encoded in the REC files released to the market so far, and in consequence no ICVC is being performed on cobas c502 for tests requiring manual reagent handling. |
| Recall action type: | Correction |
| Recall action: | Software to be upgraded |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 24/3/2014 |
