| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2024-RN-00824-1 |
| Product Name/Description |
Alinity m System, Alinity m HR HPV AMP Kit & Alinity m STI AMP Kit. An in vitro diagnostic medical device (IVD).
List Numbers: 08N53-002, 08N53-032, 09N15-090, 09N17-091
ARTG's: 260417, 324193 & 206870 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
16/09/2024 |
| Responsible Entity |
|
| Reason/Issue |
Abbott has identified an increase of incidences regarding Error Code (EC) 9198 (Positive control is non-reactive) while using the Alinity m HR HPV AMP Kit and Alinity m STI AMP Kit.
Certain invalidated positive assay controls can be traced to iron leaching into the Alinity m Lysis Solution from the lysis transfer pump in the Alinity m System.
To date, there have been no reports of adverse events related to this problem. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
Customers are advised to contact Abbott Technical Support if they are experiencing an increased incidence of Error Code 9198 (Positive control is non-reactive) while testing the Alinity m HR HPV or Alinity m STI assay for additional troubleshooting.
Abbott is working on a new pump design. Additional information will be provided when the new pump is available. |
| Contact Information |
1800 816 696 - Abbott Customer Support |