Medical device manufacturer, Trinity Biotech, has issued a medical device safety alert concerning its Captia Malaria EIA kit [Product code: 2322470; Lot number: 011]
While conducting a review of the labeling for the above mentioned kit as part of an investigation, the manufacturer discovered that an incorrect expiration date was assigned to the abovementioned kit lot number. The TMB substrate solution (lot number 523759-506036) that was included in this kit has an expiration date of November 2016. This component expiration should have been considered during the expiration date assignment of this kit lot and therefore the kit has an expiration date of November 2016 and not June 2017 as currently labeled. As the TMB in this kit is still within expiry date, no look back or result review is required on previously release results.
According to the manufacturer, the affected products are distributed in Hong Kong.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 25 July 2016