Medical device manufacturer, Biomérieux, has issued a medical device safety alert concerning its NucliSENS Lysis Buffer. [Reference number: 200292; Lot number (Expiration date): 16092902 (28 Aug 2018)]
Following a customer complaint, the manufacturer investigation has confirmed that the eluate becomes coloured because of the presence of the heme group from the hamogoblin presents in whole blood samples including Dry Blood Spot. The root cause of the coloration has been confirmed to be linked to the pH that, for lot 16092902, has been observed to be 6.9 instead of 7.1 +/-0.1 as per product specification.
According to the manufacturer, the investigation confirmed that the presence of haemoglobin causes the inhibition of the PCR resulting, in most of the cases in uninterpretable test results as also the IC would be inhibited, invalidating the test. In this case, there is a potential risk related to possible delayed results. Considering that the NucliSENS Lysis Buffer is used in various protocols and downstream applications and assuming a conservative approach and the worst case scenario in which the IC would not be inhibited, or not used although it is part of good laboratory practices, the tests run with coloured eluates could potentially result in false negative results. .
The users are advised to take the following actions:
According to the local supplier, 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 9 Mar 2017