The Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom posted a field safety notice concerning Invitech Pregnancy Test Cassettes and Dipsticks, manufactured by Invitech Ltd. All lots of products with code numbers INV-FHC-U101, INV-FHC-U102, INV-FHC-101, INV-FHC-102 and INV-FHC-202 were affected.
The manufacturer is informing customers about a change to the reading time of all Invitech pregnancy tests. The reading time for the test has been changed to 'Read results between 5 and 10 minutes after adding sample. DO NOT READ BEFORE 5 MINUTES OR AFTER 10'. Previously, the reading time for the test was between 3 and 10 minutes after adding the sample. Test lines that are very weak at 3 minutes, have better readability at 5 minutes. However ANY line in the test zone, no matter how faint, should be interpreted as a POSITIVE result.
The manufacturer has produced a more pictorial version of the instructions. These are not intended to replace the full, written version of the instructions, but to be used as a reminder on a day to day basis. They will be included in every kit. The second stage is to revise the full, written version of the kit instructions, which is now in process. Furthermore, the manufacturer advises healthcare professional using these devices to be aware of this revision to the reading time. They will be contacted to ensure they have revised worksheets and copies of the new, pictorial instructions.
For details, please refer to the following link:
http://www.mhra.gov.uk/Safetyinformation/Safetywarningsalertsandrecalls/fieldsafetynotices/CON465971
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 28 October 2014