Abbott Laboratories recalls glucose test strips
The Chicago-based company pulls back 359 million because the strips may give diabetics false low readings. So far, 22 such cases have been reported.
Reporting from Washington — Abbott Laboratories announced a recall Wednesday (12/22/2010) of as many as 359 million glucose test stripsused to monitor diabetics' blood sugar because the strips may give false low readings.
The strips may not absorb enough blood quickly enough to give a proper reading, which can lead users to try to raise sugar levels unnecessarily, or to fail to treat elevated glucose levels, the company said in a statement.
The chemically treated paper strips were manufactured at an Abbott facility in the United Kingdom between January and May 2010, according to company spokesman Scott Davies.
The defect came to light via routine in-house testing, Davies said.
Abbott, based in north Chicago, reported 22 cases of "false low" readings to the Food and Drug Administration and volunteered to conduct the recall, FDA spokeswoman Erica Jefferson said in an e-mail.
The agency is "working with the company to determine if there may be additional instances where the readings were inaccurate," Jefferson said.
Though any inaccuracy in blood sugar readings is cause for concern for diabetics, "this is an error in a safer direction, falsely low rather than falsely high," said Michael Thompson, a diabetes researcher and associate professor of medicine at George Washington University.
A false high reading could lead diabetics to overdose on insulin, triggering a dangerous hypoglycemic episode. "This isn't going to do that," Thompson said.
Abbott investigators have not determined the source of the defect, but are looking at storage conditions as a possible cause. Strips exposed to warm weather or held in prolonged storage may be more likely to yield false results.
The recall involves 359 lots of strips marketed by Alameda, Calif.-based Abbott Diabetes Care and are used with Abbott's Precision Xtra, Precision Xceed Pro, MediSense Optium, Optium, Optium EZ and ReliOn Ultima blood glucose monitoring systems.
The monitors, which read blood sugar levels in blood collected in the strips, are not affected by the recall, nor are other Abbott diabetes products
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