Events

Safety Alert for Trepanostika TP recombinant

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

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
    2013-03-08
  • Event Date Posted
    2013-03-08
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20130308.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: biomerieux trepanostika tp recombinant medical device manufacturer, biomerieux, inc., has initiated a medical device field safety correction action concerning trepanostika tp recombinant with reference no.: 285034 and 285035. the affected lot numbers are d33ga, d33ha, d33ka, d33kb, d33kc, d33ma, d33n. following customer complaints on negative control out of range, biomerieux investigation has confirmed an issue with some lots of trepanostika tp recombinant and that the problem is due to the aluminum bag that contains the microelisa strip plates. the impacted strips may contain bad aluminum bags, or a mixture of good and bag aluminum bags. as a result, customers may either experience false results or negative control out of range. the investigation also determined that the 2 lots d33ma and d33na also show a reduced sensitivity which may lead to obtain false nonreactive results. the risk is considered as critical because false nonreactive results could lead to a non-reversible injury or illness to an individual or patient that requires immediate and/or major professional medical intervention. the manufacturer advises users stop using and discard the affected product that they may have in stock. also, the manufacturer advises users that for samples previously tested with the lots d33ka, d33kb, d33kc retest the samples having results with a ratio between 0.7 and 1.3. and for samples previously tested with the lots d33ma and d33na retest all the nonreactive samples. according to the local supplier, the affected products were distributed in hong kong. if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 8 march 2013.

Device

Trepanostika TP recombinant
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: BioMerieux Trepanostika TP recombinant
  • Manufacturer
    BioMerieux

Manufacturer

BioMerieux