Abbott Diabetes Care has initiated a recall of 359 lots (approximately 359 million strips) of Precision Xtra, Precision Xceed Pro, MediSense Optium, Optium, OptiumEZ and ReliOn Ultima Blood Glucose Test Strips in the US and Puerto Rico.
The test strips are used with Abbott‘s Precision Xtra, Precision Xceed Pro, MediSense Optium, Optium and OptiumEZ blood glucose monitoring systems.
ReliOn Ultima test strips are used with the ReliOn Ultima blood glucose monitoring system and the company said that the blood glucose monitors are not being recalled and so the customers can continue to use the monitors.
Abbott Diabetes Care said the affected test strips may give falsely low blood glucose results, which can lead users to try to raise their blood glucose when it is unnecessary and to fail to treat elevated blood glucose due to a falsely low reading.
The problem appears to be related to longer than expected blood fill times and this may be dependent on the age of the strips and if the strips have been stored in (or exposed to) higher temperatures (above 72ºF and not to exceed 86ºF) for an extended period of time.
Abbott Diabetes Care will replace affected test strips at no charge to the customers who have test strips from the affected lots and said to discontinue use of the product.
Abbott Diabetes Care initiated the recall following a routine internal quality review that indicated certain lots of Precision Xtra, Precision Xceed Pro, MediSense Optium, Optium, OptiumEZ and ReliOn Ultima blood glucose test strips may experience longer than normal blood fill times which may cause falsely low blood glucose readings.