Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 24740 |
| Brand Name: | Tina-quant Myoglobin Gen.2 imprecision |
| Model: | |
| Affected: | Tina-quant Myoglobin Gen.2 (MYO2) assay on cobas c 311/501/502 with reagent lot 34986001 |
| 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: | Internal investigations have confirmed QC imprecision and calibration failures due to Dup E. It was shown that in the affected measurements a drop in the signal in the reaction kinetics occurred. This drop is most likely caused by a break-up of a precipitate triggered by mixing in a neighbouring cell. As a consequence, a decreased sample recovery is generated. |
| Recall action type: | Correction |
| Recall action: | Manufacturer to issue advice regarding use |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 20/6/2019 |
