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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 Inverness Medical Innovations Australia Pty Ltd T/A Alere
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
Contact Information 1800 622 642 - Alere Technical Support