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RECALL: Blood glucose meters (18 March 2006)The Medicines and Healthcare products Regulatory Agency has received an increased number of reports that the units of measurement on MediSense Optium Xceed, TheraSense FreeStyle Mini and TheraSense FreeStyle blood glucose meters can inadvertently be changed from mmol/L to mg/dl, leading the user to think that the blood glucose level is 18 times higher than it is. The manufacturer is now replacing affected meters with new ones for which the unit of measurement is locked to mmol/l. Affected meters include those with the following serial numbers on the back of the meter:
Pharmacists are asked not to supply affected meters and to contact Abbott pharmacy line (0800 3168844) for a free replacement. When dispensing Optium Plus test strips (used with Optimum Xceed meter) or FreeStyle test strips, pharmacists should advise the user to contact Abbott (0500 467466) to find out whether they need a replacement meter. Customers can continue to use their meter before contacting Abbott as long as they ensure that the meter is reading in mmol/l. This recall updates one issued last year (PJ, 25 June 2005, p787). |