Events

Safety Alert for NucliSENS Lysis Buffer

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by Biomérieux.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Date
    2017-03-09
  • Event Date Posted
    2017-03-09
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20170309b.html
  • Notes / Alerts
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
  • Extra notes in the data
    Medical Device Safety Alert
  • Reason
    Medical device safety alert: biomérieux nuclisens lysis buffer 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: stop using and discard any stock of the affected lot discuss any concern regarding previously reported results with the laboratory medical director to determine the appropriate course of action. 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.

Device

NucliSENS Lysis Buffer
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Biomérieux NucliSENS Lysis Buffer
  • Manufacturer
    Biomérieux

Manufacturer

Biomérieux