Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 25149 |
| Brand Name: | COBAS® AmpliPrep/COBAS® TaqMan® HCV Test, v2.0 |
| Model: | |
| Affected: | COBAS® AmpliPrep/COBAS® TaqMan® |
| 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: | The manufacturer has observed abnormal curve shapes that could lead to high titre false positive results when using either the COBAS® AmpliPrep/COBAS® TaqMan® (CAP/CTM) HC Quantitative or Qualitative, v2.0 tests. Internal investigations have found that this issue was caused by early dips” in the PCR growth curves. |
| Recall action type: | Correction |
| Recall action: | Product to be modified |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 27/9/2019 |
