image
image
Home
About Us
What's New
Medical Device Administrative Control System
Search Database
Recall and Alerts
Report Adverse Incidents
Events
Educational Materials and Publication
Frequently Asked Questions
Press Release
Download Forms
Useful Sites
Disclaimer
image Press Release
 
image
 
Recall of blood glucose meters with incorrect readings (i-sens Model CareSens II)
 

The Department of Health today (April 23) alerted the public and the medical sector, of a voluntary recall of a type of blood glucose meter (BGM)which displayed falsely low readings.

DH immediately looked into the case upon receiving notification from an informant that two BGM manufactured by i-SENS Inc, were found to display falsely low readings.

It was revealed that only one specific lot (Lot no. ISP11E02101 ¡V ISP11E02600) of the BGM was affected.

The manufacturer, i-SENS Inc, has initiated a voluntary recall through its distributor, BioScan Ltd.

According to BioScan Ltd, there were 150 BGM of the affected lot imported to Hong Kong and 106 BGM to Macao respectively.

DH has notified the Health Bureau of Macao of the recall.

Users should not use the blood glucose meters of the affected lot and seek advice from their doctors.

The department has not received any report of adverse events arising from this issue.

DH will closely monitor the recall.

The spokesman said people using the meters concerned should contact the company by calling its hotline (3589 6670) during office hours for replacement.

Ends/Thursday, April 23, 2009

 
Previous Back to Top
Medical Device Control Office
image
image
image
image 2005 copyright logo | Important notices Last revision date: 26 May 2009