Published: 7 June 2022
Safety Information
Alert
Typographical error in Healgen Rapid COVID-19 Antigen Self-Test (RATs) patient instruction leaflet
7 June 2022
The patient instruction leaflet for some Healgen Rapid COVID-19 Antigen Self-Test (RATs) have a typographical error, where the wrong word is used. The quality of the test is not affected.
Figure 1: Photos of the test kits
In the Healgen RATs patient information leaflet, under TEST PROCEDURE, point 15 ‘read your results’, a series of images is shown for the different test results. These should read ‘positive’, ‘negative’ or ‘invalid’. However, on the incorrect leaflets, the word ‘position’ has been used instead of ‘positive’. See the images below.
Figure 2: Extract from the Information For Use leaflet containing the typographical error
Products affected
Additional information
Regulator actions
Reporting
Product affected
Healgen Rapid COVID-19 Antigen Self-Test
Healgen Rapid COVID-19 Antigen Self-Tests are authorised for use in New Zealand as a testing tool for people with COVID-19 symptoms or household contacts under the COVID-19 Public Health Response (Point-of-care Tests) Order 2021. This order restricts the tests that can be used in New Zealand. For more information on RATs and to find out which RATs have been approved for use in New Zealand, please see the Ministry of Health website.
Please note that not all batches of Healgen RATs are affected by this issue; only some batches contain the incorrect patient leaflet. We know that some batches of the 1-test and 20-test packs are affected, but other pack formats may also contain the incorrect leaflet.
Additional information
There are two leaflets supplied with the affected Healgen RATs tests, one patient information leaflet and one procedure card. Only the patient information leaflet contains the typographical error. The procedure card contains the correct information for reading your test results. If you have Healgen RATs that contain the incorrect patient information leaflet, please refer to the procedure card when reading your results. The images on the outer packaging of all Healgen RATs also contain the correct information.
Medsafe has received confirmation that the typographical error is a result of an error made at the manufacturer, and the investigation has not found any evidence to indicate that there are any other issues with the quality of the tests. For further information on how to use your RAT, or how to interpret the results, please contact your healthcare provider.
Regulator actions
Medsafe is continuing to monitor this issue.
Reporting
If you have any concerns relating to this issue, please contact Medsafe at recalls@health.govt.nz.
