Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 15700 |
| Brand Name: | Abbott RealTime High Risk HPV and RealTime High Risk (HR) HPV Application CD-ROM (for m2000 System) |
| Model: | List Numbers: 02N09 & 4N05-01 |
| Affected: | Version 1.0 |
| Software version: | |
| Recalling Organisation: | Abbott Diagnostics Division Ground Floor, Building D 4 Pacific Rise Mt Wellington AUCKLAND 1640 |
| Contact Information: | 0800 656 233 |
| Manufacturer: | Abbott Molecular Inc |
| Issue: | m2000rt instrument noise is defined as an unexpected cycle-to-cycle variability in the flurorescence signals during the amplification and detection process. Abbott Molecular has identified that the instrument noise lower limit validy parameter for the RealTime HR HPV assay is set outside of the optinal setting to flag excess variability in fluroescence signal. Therefore, in the presence of excess noise, incorrect results could be generated. |
| Recall action type: | Correction |
| Recall action: | Software to be upgraded |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 21/11/2013 |
