Women and healthiness workers have actually been warned a brand of pregnancy test has actually been returning false outcomes – indicating no pregnancy, as soon as in truth the woman is carrying a baby.
The healthiness Ministry’s Medsafe division says it has actually received “several” reports from healthiness workers, district healthiness boards and clinics regarding the EasyCheck Pregnancy Test Cassette. The issues relate to “false negative test outcomes and technical faults”.
The supplier, Phoenix MedCare, says it has actually heard of just two unconfirmed cases.
Medsafe’s response has actually been to monitor reports regarding the device and to position an early warning system note on its website asking consumers and healthiness workers to notify it of issues along with the product. However, the Auckland Women’s healthiness Council labelled the response “pathetic” and is demanding a recall.
“They must grab it taken off the market,” said council co-ordinator Lynda Williams.
Medsafe is not ruling out a recall if it is warranted after further investigation.
Ms Williams said a false negative result could cause a pregnant woman believing she was not pregnant, so she could keep on drinking alcohol, which could harm the fetus. Or she could not wish to have actually a baby and a false negative result could unnecessarily delay having an abortion.
“A false negative is quite complex for women as soon as they [suspect] they are pregnant. It induces some disconnection in between their knowledge of what’s going on in their bodies and exactly what this false pregnancy checking out gives them as soon as they are pregnant.”
Jennifer Mulford and her boyfriend Brad Leeson have actually embarked on a grownup Breastfeeding Relationship. Photo / Facebook, Jennifer Mulford
The EasyCheck Test Cassette, which measures a pregnancy-related hormone degree in urine, is state-funded through Pharmac for usage by doctors, midwives and others healthiness workers. Phoenix MedCare said the Chinese-earned product was not readily available for get by the public at pharmacies.
Medsafe says the cassette test is intended to be used as a first-line pregnancy Examine from 10 days after conception and followed up along with a blood test to confirm pregnancy if there is any sort of doubt.
Family Preparation staff make constant usage of the cassette test, which is the just Pharmac-funded urine test for pregnancy, said the group’s national medical adviser Dr Christine Roke. She was aware of a handful of cases in which the cassette test had not worked properly, including some false negatives.
“Mostly it’s that they have actually been inconclusive so we’ve [retested].”
Phoenix managing director Brad Rodger said there was “one alleged report of a false negative” in December and one unconfirmed report of yet another in January. The company, which began supplying the cassette test kits last July, had supplied much more compared to 500,000 due to the fact that then.
“Throughout this period there has actually been some minor feedback along with examinations showing incomplete manage lines from isolated sites in a minor number. This is most likely because of incorrect procedural or storage techniques. We have actually not been able to replicate this issue unless we purposely follow an incorrect testing method.
“In the 12 months to December 2015 there were [around] 2.94 million of this test type supplied worldwide, along with no reportable side events.
“We do not already know the induce of both alleged false negatives. We were not supplied along with this post as soon as it was requested.”
Medsafe compliance manager Derek Fitzgerald said: “as soon as investigating claims of issues along with medical devices, [options] could consist of fault along with the product, user error or the necessity for user education. Recall of the product … could be considered after further investigation.”
The risks
• A false negative pregnancy test result could lead to:
• A woman continuing to consume alcohol, potentially harming the baby.
• An unnecessary delay in having an abortion, if the woman did not wish to have actually a baby.
• Confusion for a woman that suspects she is carrying a baby however a false test result tells her she is not pregnant.
Source: Women’s healthiness campaigner Lynda Williams
