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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 Genesis Biotech Pty Ltd
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