Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 21580 |
| Brand Name: | cobas e411 immunoassay analyser |
| Model: | |
| Affected: | All models (Disk and Rack), all software versions. |
| Software version: | |
| Recalling Organisation: | Roche Diagnostics (NZ) Ltd 15 Rakino Way Mt Wellington AUCKLAND 1644 |
| Contact Information: | 0800 363 622 |
| Manufacturer: | Patheon API Inc. |
| Issue: | In very rare cases a software malfunction in the Sample&Control datafile can occur which may lead to a potential data mismatch. This software malfunction only occurs when the "Sample Data Clear" function is not performed daily as indicated in the Operator's Manual, and when the Sample&Control datafile is filled with more than 2000 records. |
| Recall action type: | Correction |
| Recall action: | Instructions for use to be updated |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 23/6/2017 |
