| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-00856-1 |
| Product Name/Description |
Alere HIV Combo. An in vitro diagnostic medical device (IVD)
Catalogue Number: 7D2846
Lot Number: 80671K100C
Pack Size: 20 Tests
Catalogue Number: 7D2847
Lot Number: 78169K100B
Pack Size: 100 Tests
ARTG Number: 276049 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
11/07/2017 |
| Responsible Entity |
|
| Reason/Issue |
Internal investigations by Alere have identified that when testing with EDTA whole blood samples, specific lots of Alere HIV Combo may exhibit increased frequency of a red bar in the antigen (p24) result window, which could be interpreted as a false positive result. These bars may be faint. Antigen (p24) performance with other sample types continues to perform as per product specifications. Performance for HIV-1 and HIV-2 antibody is as per product specifications. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Alere is requesting customers:
1. If you have forwarded affected product to another location, provide a copy of this letter to them;
2. Review the instructions for use of the assay (and any other algorithm requirements applicable to your facility). Ensure that the requirement for retesting of initially reactive specimens is understood;
3. Ensure that initially reactive p24 antigen and/or antibody results are retested using another method and the results are evaluated in consideration of the overall clinical evaluation before a diagnosis is made; and
4. Retain the notification as part of your records.
fax or e-mail Customer Verification form to Alere Technical Support:
Fax Number 07 3363 7199 or au.techsupport@alere.com
This action has been reviewed and is considered complete in accordance with the requirements of the URPTG. |
| Contact Information |
1800 622 642 - Alere Technical Support |