Important Safety Alerts

Medical device manufacturer, Thermo Fisher Scientific, has issued a field safety notice regarding the BRAHMS Neopterin EIA. The details of the affected device are shown below:

• Kit reference number: 99.1
• Lot number (Expiry date): 703449 (16 October 2015) and 703450 (8 January 2016)

The manufacturer informs that for the BRAHMS Neopterin EIA lot 703449 and lot 703450 the"Quality Control Report", which is included in the kit, contains an incorrect range for the Quality Control K2. This might lead to validating a run, which in fact was invalid.

The manufacturer advises affected users to take the following actions:-

• Stop using the incorrect quality control range for K2 contained in BRAHMS Neopterin EIA, lot 703449 and lot 703450
• Use the correct quality control range for K2 contained in BRAHMS Neopterin EIA, lot 703449 and lot 703450 provided by the manufacturer.
• Re-evaluate all runs, which showed a value for quality control K2 between 44.4 nmol/L and 60.4 nmol/L.

According to the local supplier, the affected product is distributed in Hong Kong.

If you are in possession of the product, please contact your supplier for necessary actions.

Posted on 22 October 2015