The Department of Health (DH) has today (January 11) agreed to allow one brand of Abbott's glucose test strips, Optium Omega, to re-enter the market.
A spokesman for DH said that the decision was based on consideration of information in hand, especially the differences in design and manufacturing of Optium Omega and the supply of alternatives on the market.
DH, through its routine surveillance system, captured a US Food and Drug Administration (FDA) alert about the recall of over 380 lots, involving some 10 brands, of glucose test strips marketed by Abbott Diabetes Care in the US late last December.? This is due to ineffectiveness of the strips - there are possibilities of obtaining falsely low blood glucose readings instead.?
To allow time for proper investigation and as a precautionary measure to safeguard Hong Kong's public health, DH requested the local medical device supplier, Abbott Laboratories Limited, to recall all its glucose test strips from consumers on December 29 last year.
"As Optium Omega's unique design and manufacturing could ensure its exemption from ineffectiveness, DH thinks it reasonable to allow its re-entry into the local market, especially alternatives are not in abundance here in Hong Kong," a DH spokesman explained.
"However, any time users are in doubt of the accuracies, they should stop using the strips and consult their healthcare providers," he further remarked.
DH would continue to follow-up with the investigation and also closely monitor the recall of other brands of Abbott's glucose test strips.
Ends/Tuesday, January 11, 2010