Medical device manufacturer, BioMérieux, has issued a medical device safety alert concerning its VIDAS Cortisol S. The affected product number is 30451 and the affected lot number is 1003380350.
An error occurred during the Manufacturing Process of VIDAS Cortisol S kits (ref. 30451, lot 1003380350). The quantity of one of the raw material present in the composition of the conjugate buffer (well 5 of the VIDAS Cortisol S strips ref. 30451 lot 1003380350).
According to the manufacturer, the identified discrepancy does not affect product performance nor does it pose any health and safety risk to the end user.
The manufacturer advises users to discard any remaining inventory of the affected products and contact them for product replacement.
According to the local supplier, the affected products were distributed in Hong Kong.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 28 October 2014