Pregnancy Test Recall

When you take a pregnancy test, regardless of the scenario, you expect the results to be conclusive. While positive results are generally followed up with a visit to the GP, if the result is negative, it is rarely questioned.

It has therefore come as a shock to many that, after a review undertaken by The Therapeutic Goods Administration, a large number of home pregnancy tests have been recalled. In total, 5 brands were recalled with three more brands being investigated. Some brands were recalled, others the distributors chose to take the batches in question off the market.

On average, about 6 days after falling pregnant a woman’s HCG levels rise rapidly (levels and timelines do vary person to person). HCG is a hormone that is produced when a fertilised egg attaches to the wall of the uterus. Pregnancy tests are designed to detect the presence of this hormone in a woman’s urine sample.

This review and subsequent mass recall was sparked when three women, attending the same family clinic, used the One Step HCG pregnancy test and were issued with negative results, when in fact, their results should have been positive. Reviewers concluded that the brand in question was not sensitive enough to recognise the presence of HCG.

As a result One Step’s failure to provide an accurate result, 36 devices were to be tested, 9 companies cancelled supply and chose not to cooperate, forfeiting their Australian Register of Therapeutic Goods entry – and only 27 devices were tested. Out of the 27 that were tested, 22 proved to be accurate and were listed as adequate to provide consumers with accurate results. The 5 that failed have been recalled or supply has been ceased.

The devices that failed testing were;

  • PregSure digital, PregSure test strips (Batches 16D119-1100 16D119-0000)
  • QuickVue One-Step hCG urine test kit (Failed batches were not supplied in Australia)
  • First Response Digital Pregnancy Test, First Response Test & Reassure (Batches SU5341 SU6207 SU6237 SU6308 SU6335 SU6196 SU6305A SU6315A)
  • One Step Pregnancy Test (Failed batches were not supplied in Australia).

It must be stressed that all pregnancy tests currently in stores within Australia have been checked and approved. If you do, however, experience inconsistent or questionable results, please report your experience to TGA.

To discuss a possible pregnancy, a pregnancy test or an unplanned pregnancy contact the team of experts at Gynaecology Centres Australia.  We specialise in early pregnancy advice, family planning, provide information on pap smears, Femscreen, contraception, sterilization, Hormone Releasing Intrauterine System (IUS), abortion, fertility or reproductive health advice and a range of other gynaecological services.

Visit one of our five gynaecology clinics in Wollongong, Canberra, Newcastle, Gosford or Sydney – or find us online at
For more details on the recent pregnancy test recall, visit

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