Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 13903 |
| Brand Name: | Roche COBAS TaqMan MTB Test Definition File |
| Model: | |
| Affected: | Version 3.0 |
| Software version: | |
| Recalling Organisation: | Roche Diagnostics (NZ) Ltd 15 Rakino Way Mt Wellington AUCKLAND 1644 |
| Contact Information: | 0800 363 622 |
| Manufacturer: | Roche Molecular Diagnostics |
| Issue: | The MTB Test Definition File (TDF) v3.0 has an incorrect Target Elbow Max cutoff value of 48. The correct Target Elbow Max cutoff value should be 50. |
| Recall action type: | Correction |
| Recall action: | Software to be upgraded |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 7/12/2012 |
