A widely-used pregnancy test is being investigated by Medsafe after reports of false outcomes – however the business that makes it is status by its product.
Photo: AFP
The EasyCheck Pregnancy Test Cassette is government-subsidised and is used in hospitals, medical practices and by Family Planning.
Medsafe said in a safety alert it had received several reports from clinicians, district good health boards and community providers concerning either false negatives or technical faults.
The medicine and medical device authority said it was monitoring the reports.
It said it had asked the supplier, Phoenix MedCare, for a lot more article concerning the device to locate out exactly what sort of errors there had been and exactly how many.
But Phoenix MedCare said the product was constantly tested by independent labs and was executing well.
Its regulating director, Brad Rodger, said due to the fact that last July Phoenix had distributed half a million examinations and just heard of 2 potential cases of false negative examinations from Medsafe and a handful of inconclusive results.
That was well listed here acceptable levels for erroneous examinations per batch, he said.
But Auckland Women’s good health Council wanted the examinations recalled immediately, saying any type of doubt concerning the quality was also much.
Its spokeswoman, Lynda Williams, said an incorrect result was a big concern.
“It’s denying women time to make options concerning whether they keep on to consume alcohol, and whether this pregnancy is welcome or not welcome,” she said.
“They might be believing of terminating the pregnancy so there is a demand for women to be offered reassurance that the testing kits are a lot more reliable compared to this one appears to be.”
Family Preparing uses the tests, and said it has actually had a small variety of reports of problems.
Its medical advisor, Christine Roke, said the majority of of those have actually been concerning the outcomes being unclear, very compared to wrong.
But a false negative result would certainly be a significant problem, she said.
“every one of examinations do have actually wrong outcomes occasionally so it is necessary for individuals to be aware that if they have actually a result that they don’t believe is right, after that they have to consider whether to repeat the test or seek some tips concerning it,” Dr Roke said.
Mr Rodger said it was feasible for the tests, which measure hormone levels in urine, to deteriorate or for individuals to usage them wrongly.
“If you’re testing later in the day and there has actually been a great deal of fluid intake, for example, that could dilute your urine and if you are pretty early on in pregnancy, state 10 days or show, it could prove to a negative result.”
