Press Release

Press Release

Further recall of selected lots of FreeStyle Lite blood glucose test strips

26 Nov 2013

The Department of Health (DH) today (November 26) drew public attention to Abbott Diabetes Care's further recall of other selected lots of its FreeStyle Lite blood glucose test strips due to the potential for giving erroneously low blood glucose results when used in conjunction with certain brands of blood glucose meters also manufactured by the company.

Further to the press release issued by the DH yesterday (November 25) on the recall of certain lots of FreeStyle and FreeStyle Lite blood glucose test strips by Abbott Diabetes Care, the department, through its routine surveillance on medical devices, noticed Abbott Diabetes Care's recall notice posted by the United Kingdom's Medicines and Healthcare products Regulatory Agency involving three other lots of FreeStyle Lite blood glucose test strips (lot numbers: 1284962, 1366626 and 1372611).

According to the notice, the three affected lots may produce erroneously low blood glucose results and out of range control solution results when used in conjunction with FreeStyle blood glucose meters, FreeStyle Mini blood glucose meters, FreeStyle Navigator and the FreeStyle meter built into the Omnipodsystem.

A spokesman for the DH explained that falsely low blood glucose readings may mislead a diabetic patient into inappropriate management of his or her condition, resulting in hyperglycaemia.

"Preliminary enquiries with the local supplier, Abbott Laboratories Limited, revealed no evidence of the affected products having been distributed in Hong Kong. The DH will continue to monitor the situation," the spokesman said.

So far, the DH has not received any local reports of adverse events arising from use of the affected products.

People who have the test strips belonging to the affected lots and are using the specific brands of glucose meters concerned should contact Abbott Laboratories Limited for advice and follow-up," the spokesman stressed.

The company has set up a customer service hotline, 5808 4196, to answer related enquiries.

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