The Department of Health (DH) has directed local supplier Abbott Laboratories Limited to recall 359 lots of glucose test strips which may give falsely low blood glucose results today (December 23).
The recall followed assessment of a US Food and Drug Administration (FDA) alert, captured by DH's routine surveillance system, which involved the recall of 359 different lots of glucose test strips marketed by Abbott Diabetes Care in the US under the following brand names:
* Precision Xceed Pro;
* Precision Xtra;
* MediSense Optium;
* Optium;
* OptiumEZ; and
* ReliOn Ultima
The blood glucose monitoring systems are not affected by this recall.
More details of the recall are posted under FDA News (Medical Devices) and the Abbott Diabetes Care respectively:
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm237900.htm
http://www.precisionoptiuminfo.com/img/Lot-Numbers.pdf
According to initial information from the local supplier, at least the following items and lot numbers in the list of test strips are available in Hong Kong:
MediSense Optium Blood Glucose Electrodes
* Lot 45001A137
* Lot 45001A921
Precision Xceed Pro Blood Glucose Test Strips
* Lot 44CR5H
Abbott's records revealed that some 6,000 boxes of the above lots are available in Hong Kong.
A spokesman for DH said although records showed that only three lots were shipped to Hong Kong, it was necessary to recall all 359 lots of products as some products might have been directly brought back to Hong Kong by consumers or purchased over the Internet.
So far, the DH has not received any report of adverse events arising from the affected products.
Members of the public should stop using any of the 359 lots of products and contact healthcare professionals if in doubt.
They may contact the company at hotline 2806 4488 daily from 9am to 5pm for recall arrangements.
Hospitals, medical associations and nursing homes have been alerted. The department will closely monitor the recall. Investigation continues.
Thursday, December 23, 2010