Numerous pregnancy test kits have been withdrawn from sale in Australia after they were found to be unreliable and inaccurate.

Therapeutic Goods Administration recently reviewed a wide range of pregnancy self-test kits that rely on detecting the hormone known as human chorionic gonadotropin, or hCG, in a woman’s urine shortly after conception, reports AAP.

“Some devices were found not to work reliably and accurately and have either been corrected or removed from the market,” the TGA said in a statement.

“All devices remaining on the market in Australia have been shown to work reliably and accurately.”

The TGA tests focused on claims by the test kits’ makers that they could detect extremely low levels of hCG as early as the first week after conception.

The hormone hCG is produced by cells that will develop into the placenta, with levels rising rapidly once a woman is pregnant.

The TGA began testing pregnancy kits after receiving reports of three false negative results of the One Step HCG urine pregnancy test from a family planning clinic.

The regulator found the kits to be “insensitive”, prompting a recall from shop shelves and them being cancelled from the Australian Register of Therapeutic Goods (ARTG).

“All affected batches were recalled from pharmacies,” the TGA said.

“An investigation by the sponsor revealed a manufacturing flaw, which was corrected and the corrected devices were found to pass in subsequent testing.”
* PregSure digital – recalled and cancelled from sale
* Pregsure test strips – recalled and cancelled from sale
* QuickVue One-Step hCG urine test kit – removed from sale by manufacturer
* One Step Pregnancy test – removed from sale by manufacturer
* First Response Digital Pregnancy Test/First Response Test & Reassure – manufacturing fault corrected

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  • I have done that myself, my father was rushed to hospital and I waited to catch a plain. Nothing wrong with placing your child on the floor she has a blanket down baby is safe .


  • So terrible if you are depending on them to be accurate.


  • Gee, a number of them listed, bit disappointing.


  • Glad these tests were taken of the market, they should be reliable and accurate.


  • I always bought packs of 20 test strips off ebay. It cost about $3 and you can go nuts testing as often as you want. They were always very accurate.


  • I wonder if they were also in supermarkets, since those brands are also sold there.

    • The articles seems to indicate that the recall only impacted pharmacies. Good question.


  • i always had used first response with my situations lol. i hadn’t heard of this recall though so thanks for sharing this information


  • What a mistake to have made!!


  • Glad to see they took them off the market if they were incorrect.


  • Yeah this is good to know there are checks and balances because this kind of thing really matters.


  • This is definitely a product that needs to work properly!


  • yep, my friend had three negative results and then was concerned when she brought another kit and all three of those said negative as well. She thought she had cancer or something sinister was going on-9 weeks later she welcomed her 5th baby into the world!!


  • Not an issue for me, but not really something you want to be inaccurate. I do know they’re mostly 99% accurate, but if you’re relying on the results… it’s a little worrying!


  • A good community notice and information for anyone buying/needing a pregnancy kit. Interesting that it was only ones at pharmacies.


  • Glad they found the problem and sorted it, could’ve been scary if women didn’t know they were pregnant and still drank alcohol etc.


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