Recall of at Home Pregnancy Tests Giving False Negatives
Trying for a baby is such an intense time of trepidation and surging mix of emotions, that faint blue line can hold so much potential, the downfall of an inaccurate reading can be devastating. It is beyond shocking that almost half the home pregnancy tests available in Australia have be pulled from the shelves after receiving reports of negative tests results using the product!
The Therapeutic Good Administration has conducted a sweeping review of the DIY testing kits to ensue they meet sensitivity claims, with unsure and detrimentally worrying results.
There are more than 30 self-test urine pregnancy test kits on the market and of that, 14 have ceased sale or have been recalled across Australia.
The crackdown was issued 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.
When contacted by the regulator to provide information on the devices, nine suppliers withdrew their products from sale foregoing any 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 identify 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. This including some that have claimed to be able to detect extremely low levels as would be found in the first week after conception, 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 voluntarily recalled remain anonymous.
Consumers are being urged to return all recalled kits to a pharmacy for an exchange or a refund, Choice said.
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.
If you have doubts about the conclusiveness of your at home pregnancy test results, go to your GP, request a blood test and cover all bases. You know your body and you know when something has changed or simply is feeling different, trust that and seek advise. It is incredibly disheartening that so many tests have been proven to be unreliable with such an immensely sensitive moment like conception.