The U.S. Food and Drug Administration (FDA) has issued a recall of several brands of diabetes test strips manufactured by Abbott Laboratories. Diabetes test strips are produced in lots, which diabetics then match against their testing meter. This recall includes 359 different lot numbers manufactured between January and May 2010. The strips were sold in a variety of places, including online and in stores. Healthcare professionals also distributed the strips to patients in hospitals and other facilities.
Details of the Diabetes Test Strip Recall
The recall could include up to 359 million test strips that were originally distributed in the U.S. and Puerto Rico. According to the FDA, the strips are used with "Abbott’s Precision Xtra, Precision Xceed Pro, MediSense Optium, Optium, Optium EZ and ReliOn Ultima blood glucose monitoring systems." The testing systems, and any other Abbott Diabetes Care products, are not part of the recall. The company estimates that it will take roughly eight weeks to replace all the defective strips.
Blood Glucose Test Strips Defective
When a diabetic tests his blood glucose level, he must prick his finger to get a small drop of blood. This drop of blood is then placed on a testing strip and inserted into a monitoring system. The defective strips are being recalled because they do not absorb enough blood to get an accurate blood glucose reading.
Another problem with the strips is that, if stored over time in a warm place, they could register a false readout. According to WebMd, both these situations are dangerous because it "can lead users to try to raise their blood glucose when it is unnecessary or to fail to treat elevated blood glucose due to a falsely low reading."
What to Do if You Have the Defective Test Strips
Consumers should contact Abbott Diabetes Care customer service at 1-800-448-5234 (English) and 1-800-709-7010 (Spanish) to talk to a representative who can determine if they have the defective strips. People can also log on to the Abbott website and compare the strip lot numbers with what they have at home. Anyone with a defective box will receive a free replacement.
If consumers run out of testing strips as a result of this recall, they should contact their health professional immediately to obtain an alternate testing method. The FDA is also monitoring any side effects that occur as a result of this recall. Diabetics should report any related issues to the MedWatch Adverse Event Reporting program.
Sources:
FDA, "FDA announces recall of Abbott glucose test strips," December 22, 2010 (accessed December 23, 2010).
Red Orbit, "FDA Announces Recall of Abbott Glucose Test Strips," December 22, 2010 (accessed December 23, 2010). WebMd,
"Recall of Defective Glucose Test Strips," December 22, 2010 (accessed December 23, 2010).
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