Three types of pregnancy test have been recalled and 14 have been completely removed from sale after women began reporting false negatives and test manufacturers refused to provide requested information about their products to the Therapeutic Goods Administration (TGA).
False negative results
We all know the business of pregnancy is a serious one, so the news that lots of pregnancy tests are less than accurate and pregnancy test-makers have been less than transparent is worrying, to say the least.
The TGA says this all started when three women reported false negative results after using the One Step HCG urine pregnancy test, sparking a TGA investigation.
The regulator found that the test was not sensitive enough to detect the pregnancy hormone (hCG) and should be removed from sale. It also prompted a broader review of other pregnancy self-test kits on the Australian market – including two tests being sold locally on eBay.
“The TGA has completed a review of all human chorionic gonadotropin (hCG) pregnancy self-test kits on the Australian market to ensure they meet sensitivity claims,” a TGA spokesperson said in a statement earlier this week.
“Some devices were found not to work reliably and accurately and have either been corrected or removed from the market. All devices remaining on the market in Australia have been shown to work reliably and accurately.”
Avoiding the regulator
Pregnancy self-test kits sold in Australia must appear on the Australian Register of Therapeutic Goods (ARTG). In the wake of the reported failed tests, the TGA contacted all the manufacturers whose pregnancy test kits appear on the register. Their responses were far from reassuring.
“Nine manufacturers chose to stop local sales rather than provide the requisite information. Another two tests were cancelled by the TGA for being improperly included on the register,” Choice reports.
That left 27 pregnancy test kits on the register, five of which failed further TGA testing.
In a statement earlier this week, the TGA revealed they are considering further action against one manufacturer, Thermo Fisher Scientific Australia, and urged consumers to return recalled pregnancy self-test tests to the point of purchase for a refund.
Recalled pregnancy test kits
So far, the TGA has identified the following kits as banned or recalled:
PregSure digital AND PregSure test strips
Batch numbers – 16D119-1100 and 16D119-0000
QuickVue One-Step hCG urine test kit
Failed batches were not supplied in Australia
First Response Digital Pregnancy Test (also included in First Response Test & Reassure)
Batch numbers – SU5341, SU6207, SU6237, SU6308, SU6335, SU6196, SU6305A, SU6315A
One Step Pregnancy test
Failed batches were not supplied in Australia.
The TGA urged consumers and health professionals to report problems with these devices for follow-up investigation.