Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 21590 |
| Brand Name: | Cobas modular analytic series system |
| Model: | |
| Affected: | Immunochemistry module cobas e 602, cobas e 601 and E170 modules, cobas 8000 modular analyzer series, cobas 6000 analyzer series, MODULAR ANALYTICS, MODULAR ANALYTICS EVO |
| Software version: | |
| Recalling Organisation: | Roche Consumer Health, Division of Roche Products (NZ) Limited 8 Henderson Place Te Papapa AUCKLAND |
| Contact Information: | |
| Manufacturer: | Patheon API Inc. |
| Issue: | In very rare cases when a number of specific conditions are met, it is possible that a sample mismatch may occur in the immunochemistry modules (cobas e 602, cobas e 601 and E170 modules) due to a software limitation. If the Gripper fails to pick up a sample vessel (cup) for a sample on the rack being assayed, the measurement for that sample is cancelled and the warning "Tip/Cup pick up error" (Caution Level) is issued. |
| Recall action type: | Correction |
| Recall action: | Product to be modified |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 28/6/2017 |
