Events

Safety Alert for VITEK 2 AST-P586 Test Kit 20 Cards

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
    2017-02-15
  • Event Date Posted
    2017-02-15
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20170215b.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 vitek 2 ast-p586 test kit 20 cards medical device manufacturer, biomérieux, has issued a field safety notice concerning its vitek 2 ast-p586 test kit 20 cards (lot number: 366386410; expiration: 13 jul 2017). the manufacturer received customer reports regarding an issue related to out-of-range-low (oorl) ampicillin/sulbactam qc results for escherichia coli atcc 35218, a package insert qc strain, in association with vitek 2 ast-p586 test kit, lot 366386410. internal investigation at the manufacturing site has confirmed the oorl ampicillin/sulbactam qc results. in addition, the investigation determined the ampicillin/sulbactam mic results for the gram-positive organisms claimed by the vitek 2 ast-p586 test kit are not affected (i.E. staphylococcus spp., enterococcus spp. and streptococcus agalactiae). according to the manufacturer, the issue is limited to the affected lot. there are no reports or evidence to suggest the issue exists for any other test kit lot. evaluation of the identified issue indicates no potential for erroneous patient mic results due to the oorl ampicillin/sulbactam qc result. however, escherichia coli atcc 35218 must be repeated to success, or an alternate method must be used to obtain ampicillin/sulbactam mic results the manufacturer advises users to dispose of the remaining affected lot in their stock. product replacement is on-going according to the local supplier, the affected products are distributed in hong kong. if you are in possession of the products, please contact your supplier for necessary actions. posted on 15 february 2017.

Device

VITEK 2 AST-P586 Test Kit 20 Cards
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: BioMérieux VITEK 2 AST-P586 Test Kit 20 Cards
  • Manufacturer
    BioMérieux

Manufacturer

BioMérieux