Events

Safety Alert for Etest Ertapenem

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
    2014-02-12
  • Event Date Posted
    2014-02-12
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20140212.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 etest ertapenem medical device manufacturer, biomerieux, has issued a field safety notice concerning certain lots of the following products: etest ertapenem - foam etp 32 – 30 tests (reference: 531610); etest ertapenem- foam etp 32 – 100 tests (reference: 531618); etest ertapenem etp 32 – single pack of 30 tests (reference: 412332) the manufacturer identified a performance issue on the etest foam ertapenem (reference 531610 and 531618) and etest single pack ertapenem (reference 412332). these strips did not give the correct minimum inhibitory concentration (mic) for some of quality control strains. for non-enterobacteriaceae (quality control purpose), the mic shift over the time can be greater than +1 dilution when compared to the mics initially obtained at the time of the release. for enterobacteriaceae, the over-estimation of mic can change the category result of isolates having mic equal or close to the breakpoint. according to the manufacturer, this performance issue leading to this over-estimation of mic can be detected using the quality control as recommended in the etest package insert. the manufacturer advises users to discontinue using and to destroy the affected kits. it will provide replacement kits as soon as a new batch of etest ertapenem is available. according to the local supplier, the affected products were distributed in hong kong. if you are in possession of the products, please contact your supplier for necessary actions. posted on 12 february 2014.

Device

Etest Ertapenem
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Biomerieux Etest Ertapenem
  • Manufacturer
    Biomerieux

Manufacturer

Biomerieux