| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-00620-1 |
| Product Name/Description |
RAPID Hp StAR Kit (used in the detection of H. pylori). An in vitro diagnostic medical device (IVD)
Product Code: K671411-2
Lot Number: HP1115
ARTG Number: 235688 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
10/05/2016 |
| Responsible Entity |
|
| Reason/Issue |
An internal technical investigation by Oxoid Limited, has identified that the affected lot may give a weak false positive line with no H. pylori antigen present, making interpretation of test results more difficult than with previous batches. Continued use of this lot may result in a delayed or false positive results reporting. |
| Recall Action |
Recall |
| Recall Action Instructions |
Thermo Fisher is advising users to inspect stock and remove any remaining product of the affected lot number from use. A credit note will be issued.
A review of previously generated patient results is at the discretion of the Laboratory Director. This action has been closed-out on 03/02/2017. |
| Contact Information |
08 8238 9044 - Thermo Fisher Scientific |