FDAnews Device Daily Bulletin
Quality / Medical Devices / Regulatory Affairs / Postmarket Safety / Commercial Operations

MHRA Issues Warning About Two Abbott Diabetes Care Blood Glucose Meters

March 14, 2014

A Feb. 19 recall of Abbott Diabetes Care’s FreeStyle Blood Glucose Meter and FreeStyle Mini Blood Glucose Meter prompted the UK’s Medicines and Healthcare products Regulatory Agency to issue Thursday a warning about the products, which may produce incorrect results.

The meters may give low blood glucose results when used with Abbott’s FreeStyle Lite and FreeStyle blood glucose test strips, the company says.

Though no such product has been sold in the UK since 2007, MHRA believes that 11,000 people may still be using the products.

Also on Feb. 19, Abbott issued a warning that the FreeStyle Navigator 1.0 and 1.5 continuous blood glucose monitoring system also may produce incorrect readings when used with its separately marketed test strips.

Overall, 26 countries are affected by the recall, spanning the U.S., Europe and Asia, Abbott Diabetes Care told Device Daily Bulletin.

Patients with an affected FreeStyle Navigator device may call the company to receive new test strips. Patients with a FreeStyle or FreeStyle Mini meter may call the manufacturer to receive a replacement device.

This is not the first recall for a FreeStyle diabetes product. In November, the FDA issued a recall notice for Abbott Diabetes Care’s FreeStyle and FreeStyle Lite test strips, also for producing low blood glucose readings, a potentially life-threatening complication. Last summer, Abbott also recalled its FreeStyle InsuLinx meters for producing the exact opposite result. — Lena Freund

Subscribe to Devices & Diagnostics Letter for complete coverage of the medical devices industry. Click here for more information.