Important Safety Alerts

Medical device manufacturer, Alere, has issued a medical device safety alert concerning Triage Cardio 3 with catalogue number 97400 and lot number W53658B.

According to the manufacturer, the affected product was investigated in response to date observed as part of the manufacturer's routine product performance monitoring program. This lot shows lower than expected result for BNP, CKMB and Troponin I which in turn could result in an increased rate of false negative results. Testing of external controls would enable the lab to detect if this lot was giving lower than expected results at the time of testing.

The manufacturer advises users of the followings:

• If users have questions about previously reported results, they should consult with resident clinical expert or physician in the setting where the test was performed.
• Users should discontinue use of and discard the affected products. Product replacement will be arranged by the manufacturer.

According to the manufacturer, 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 20 February 2014