Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 21422 |
| Brand Name: | cobas 4800 HPV Amplification/Detection Kit |
| Model: | |
| Affected: | Lot numbers X10763, X09600, X13438, Y00444 |
| Software version: | |
| Recalling Organisation: | Roche Diagnostics (NZ) Ltd 15 Rakino Way Mt Wellington AUCKLAND 1644 |
| Contact Information: | 0800 363 622 |
| Manufacturer: | Roche SAS |
| Issue: | The manufacturer is advising that certain lots of the cobas® 4800 HPV Amplification/Detection Kit are generating an increase in the frequency of invalid Positive Control (PC) results, causing the entire run to be invalidated on the cobas® 4800 System. |
| Recall action type: | Recall |
| Recall action: | Product to be destroyed |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 15/5/2017 |
