| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-00230-1 |
| Product Name/Description |
PregSure Digital Pregnancy Test & Pregsure Pregnancy Test. An in vitro diagnostic medical device (IVD).
PregSure Digital Pregnancy Test
Catalogue Number: LS-620
Batch Number: 16D119-1100
PregSure Pregnancy Test (midstream)
Catalogue Number: LS-633
Batch Number: 16D119-0000
ARTG Number: 236402 |
| Recall Action Level |
Retail |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
27/02/2017 |
| Responsible Entity |
|
| Reason/Issue |
Genesis Biotech Pty Ltd has been advised that testing by theTGA has identified that two batches of PregSure Digital Pregnancy test strips and PregSure Pregnancy test strips were not sensitive to hCG at 25 mIU/mL. Consequently, these batches are being recalled. |
| Recall Action |
Recall |
| Recall Action Instructions |
Pharmacies are to inspect stocks and quarantine all units from the affected batches. Genesis Biotech will arrange for the quarantined stock to be recovered and replacement stock or a credit note to be issued.
This action has been closed-out on 19/03/2018. |
| Contact Information |
07 3472 5662 - Genesis Biotech |