Events

Safety Alert for VIDAS FSH

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
    2018-03-09
  • Event Date Posted
    2018-03-09
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20180309.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, vidas fsh medical device manufacturer, biomérieux, has issued a medical device safety alert concerning its vidas fsh. the affected products are identified as below: product references: a) 30407; b) 30407-01. lot numbers: a) 1005888220, 1006006370, 1006080890, 1006094700 and 1006214640; b) 1005888210. the manufacturer has received several complaints for invalid calibration with low calibrator s1 while using vidas fsh reference 30407 / 30407-01. tests performed in-house confirmed a decrease of the strips signal overtime for the impacted lots. according to the manufacturer, the defect was highlighted with complaints for invalid calibration, but concerns all testing performed (calibration and patient’s samples testing). the investigation concluded that this could have an impact on patient results. there are two possible situations as following: in case of invalid calibration: an error message appears and it will not be possible to perform further testing with the concerned lot. in this context, the risk for patients is a delayed result due to invalid calibration. in case of valid calibration: false results (falsely overestimated or falsely underestimated results) may happen. affected users are requested to destroy the impacted lots. for tests previously performed using the impacted lots of vidas fsh, the affected users are asked to discuss any concerns they may have regarding previously reported patient results obtained with the clinicians to determine the appropriate course of action. results should be reviewed and interpreted within the overall clinical context. 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 march 2018.

Device

VIDAS FSH
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: BioMérieux, VIDAS FSH
  • Manufacturer
    BioMérieux

Manufacturer

BioMérieux