| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-01238-1 |
| Product Name/Description |
Dengue NS1 Ag Strip
Catalogue Number: 70700
Serial/Lot Numbers:
5F0130 Expiry Date: 30 March 2016
5H0131 Expiry Dates: 30 April 2016 and 15 May 2016
5H1131 Expiry Dates: 30 April 2016 and 15 May 2016
5H2131 Expiry Dates: 30 April 2016 and 15 May 2016
ARTG Number: 207118
An in vitro diagnostic medical device (IVD) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
22/12/2015 |
| Responsible Entity |
|
| Reason/Issue |
There has been a sudden degradation of the sensitivity of certain lots of Dengue NS1 Ag Strips, which has resulted in false negative results for positive patient samples. |
| Recall Action |
Recall |
| Recall Action Instructions |
Bio-Rad is advising users to inspect stock (including units currently in use) and discard the affected units. Affected lots will be replaced. This action has been closed-out on 30/08/2016. |
| Contact Information |
1800 224 354 - Bio-Rad |