Published: 17 May 2016
Revised: 9 December 2016

Safety Information

Early Warning System - Monitoring Communication

Medsafe emphasises that patients should NOT stop using any medicine or medical device subject to a monitoring communication. If you have any concerns with a medicine or medical device you are using, please contact your health professional. A monitoring communication does not mean that the medicine or medical device causes an adverse event.

EasyCheck hCG Urine Pregnancy Test Cassette – Invalid (Negative) and Inconclusive Results

17 May 2016

Monitoring finishes 26 November 2016

Medsafe has received several reports from Clinicians, DHB’s, Clinics and community providers, describing a series of problems relating to false negative test results and technical faults.

Products Affected

EasyCheck Pregnancy Test Cassette

Additional Information

This test is funded for the use in rapid, one step testing for the qualitative detection of hCG in urine as an early detection of pregnancy from 10 days after conception. It is intended to be used as a first line check and followed up with a blood test to confirm pregnancy if there is any doubt.

Regulator Actions

Medsafe is continuing to monitor reports relating to this device.

Reporting

Consumers and healthcare professionals are encouraged to report problems with this product to Medsafe

Medsafe cannot give advice about an individual’s medical condition.  If you have any concerns about a medicine you are taking Medsafe encourages you to talk to your healthcare professional.

Update to Original Communication (9 December 2016)

Medsafe received 30 reports following publication of the above monitoring communication; 26 from DHB’s or health centres and 4 from pharmacies or the public.

The issues reported mainly related to technical problems with the product such as absent or incomplete, control lines. Reports of incorrect results were also received.

Medsafe has received and reviewed documentation requested from the company relating to the manufacturing and the quality control associated with the production of the product. The documentation reviewed indicates EasyCheck meets the internationally accepted requirements for this type of InVitro Device (IVD). 

To date the Medsafe investigation has not identified any evidence that EasyCheck does not meet the requirements as a qualitive point of care test (IVD).

No further action is proposed to be taken by Medsafe. 

Medsafe will re-investigate this concern should more information become available.