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The Therapeutic Goods Administration (TGA) has conducted a review of the home pregnancy test market, the results found fourteen brands being ceased from sale in Australia and the recalls of three more.

That is nearly half the home pregnancy tests available in Australia which have been pulled from the market after pregnant women received negative results using the kits.  Of more than 30 self-test urine pregnancy test kits on the market, 14 have ceased sale or been recalled across Australia.

The Therapeutic Good Administration has conducted a sweeping review of the DIY testing kits to ensue they meet sensitivity claims, with worrying results.

The crackdown was prompted after a report of three false negative results using the One Step HCG urine pregnancy test from a family planning clinic.

The TGA tested the product, finding it to be “insensitive”, recalled and cancelled it from the Australian Register Therapeutic Goods, and proceeded to test the remaining pregnancy test kits on the register.

After being contacted by the regulator to provide information on the devices, nine suppliers withdrew their products from sale rather than undergo testing. Another two were removed from the ARTG by the TGA for being improperly included.

Of the remaining products, five were found to be ineffective and have been recalled and removed from the ARTG. The TGA is considering “further regulatory action” against one supplier: Thermo Fisher Scientific Australia, which produces the QuickVue One-Step hCG urine test kit.

Pregnancy tests are designed to tell if urine contains the hCG hormone, which is produced by cells that will develop into the placenta after a fertilised egg attaches to the wall of a woman’s uterus, the TGA explains.

The kits that were found faulty were found to be ineffective in detecting the hCG hormone — including some that have claimed to be able to detect extremely low levels as would be found in the first week after contraception, the TGA said.

“All devices remaining on the market in Australia have been shown to work reliably and accurately,” a statement from the regulator assured.

Consumer advocacy organisation Choice has expressed concern that the regulator has only released details of five of the kits that have been recalled.

Only names of the kits that failed testing have been made public. The products that were voluntary recalled remain unknown.

Consumers are being urged to return all recalled kits to a pharmacy for an exchange or a refund, Choice said.

RECALLED PRODUCTS
PregSure digital: Batch 16D119-1100

PregSure test strips: Batch 16D119-0000

First Response Digital Pregnancy Test and First Response Test & Reassure: Batches SU5341, SU6207, SU6237, SU6308, SU6335, SU6196, SU6305A, SU6315A

One Step Pregnancy test has been removed from the ARTG and ceased supply, though failed batches were not supplied to Australia.

QuickVue One-Step hCG urine test is having further regulatory action considered against its sponsor, though failed batches were not supplied to Australia.

Details of the nine products voluntarily withdrawn from sale have not been released.

Have you experienced an issue with home pregnancy tests? We would love to hear your story.
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Image: Stock photo

  • yeah this should be something that a doc confirms officially so that you can get your referral for the hospital

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  • Stop feeding us misleading info. Headlines state “RECALL: Massive recall of home pregnancy tests across Australia.”

    Just check the product safety website and there is 2 brands. Yep 2!! Such a MASSIVE number isn’t it.
    If they have been recalled in Australia then they should be listed on the website but they’re not!!

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  • This is not such a big deal is it?! If you suspect you’re pregnant, you usually go to a Dr for confirmation anyway

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  • Gee this is a real concern.

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  • I suspect there is going to be a huge shortage of Home Pregnancy Test Kits. Looks like the Doctors are going to have to wait for official laboratory results before they give a patient definite results.

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  • This happened to me in 2014- I was pregnant with my son, took 2 tests at home and one at the doctors and all 3 came back negative despite the fact that I was feeling exhausted and a low appetite at night, not being able to complete my normal exercise, etc. Doctor did a follow up blood test and sure enough I was actually pregnant! I was 5 weeks along before we found out.

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  • Ooh, not the product you want to mix things up. I imagine there has been many stressed out customers.

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  • Glad these ones were recalled but all should be published and publish the ones that are found to work 100% of the time.

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  • Not pretty ! Glad those faulty products got recalled.

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  • An important recall for sure!

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  • Good to be informed,you never know people will be using these and they need the correct results!

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  • good to do a recall as you need to know.

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  • My friend did 3 home pregnancy tests and all showed negative. She then went to the Dr thinking something was seriously wrong with her only to find she was 6 months pregnant!

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  • This is not much chop at all! These home test kits are not always right. Best to have it done by a gp!

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  • I knew i was pregnant, negative with one step test, tried a different brand and yup big fat positive, not like it was to early test either was around 6 weeks when i tested!

    Reply

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