| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-01057-1 |
| Product Name/Description |
Abbott RealTime HIV-1 Assay. An in vitro diagnostic medical device (IVD)
List Number: 02G31-010
Lot Number: 475025
ARTG Number: 217841 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
15/08/2017 |
| Responsible Entity |
|
| Reason/Issue |
Abbott Molecular has identified that a specific lot of Abbott RealTime HIV-1 Assay may exhibit a higher than expected rate of error codes. For Plasma samples, this has the potential to exhibit false “Not Detected” results for HIV samples less than 120 Copies/mL when using 0.6 mL assay application. For Dried Blood Spot (DBS) samples when using a 1-Spot protocol associated with the RealTime HIV-1 Package Insert 51-608282, these are performing in accordance with the detection rate within the RealTime HIV-1 package insert for DBS sample types. |
| Recall Action |
Recall |
| Recall Action Instructions |
Abbot is requesting users:
1. Review the supplied Abbott Molecular letter carefully and follow the instructions;
2. Complete and return the supplied Customer Reply Form;
3. Contact Abbott Customer Service for assistance if needed.
If customers have forwarded the affected product to other laboratories, inform them of this Product Recall and provide to them a copy of the customer letter; and
4. Retain this letter for your laboratory records.
This action has been closed out on 24/03/2020 |
| Contact Information |
1800 816 696 - Abbott Customer Support |