| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-00309-1 |
| Product Name/Description |
Imagine Instant Pregnancy Test
Pack Size: 20
Batch Number: 411069
Expiration Date: 10/2014 |
| Recall Action Level |
Retail |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
5/04/2013 |
| Responsible Entity |
|
| Reason/Issue |
Point of Care Diagnostic has received a number of complaints of false positive and negative test results for the Imagine Instant Pregnancy Test.
This recall action was carried out prior to approval of the recall strategy by the Therapeutic Goods Administration. |
| Recall Action |
Recall |
| Recall Action Instructions |
Point of Care Diagnostics recovered remaining potentially affected stock from hospitals and retailers and replaced with an unaffected batch. |
| Contact Information |
1800 640 075 - Point of Care Diagnostics |