Abbott Laboratories is recalling as many as 359 million glucose test strips used by diabetics to monitor their blood sugar because the strips could give low readings.
The recall, announced Wednesday, indicates the strips may not work properly because they may not draw enough blood to give an accurate reading. Users may then unnecessarily raise their sugar levels or fail to treat glucose levels that are too high, according to the company.
Abbott spokesman Scott Davies said the strips were made at a company facility in the United Kingdom earlier this year. Davies said the defect was discovered through in-house testing.
The company had reported 22 cases of low readings to the Food and Drug Administration and voluntarily issued the recall, said Erica Jefferson of the FDA.
The FDA is “working with the company to determine if there may be additional instances where the readings were inaccurate,” Jefferson said in an e-mail.
Any false reading of blood sugar levels should concern diabetics, but “this is an error in a safer direction, falsely low rather than falsely high,” said Michael Thompson, a diabetes researcher at George Washington University.
Investigators with Abbott have not found the cause of the defective strips, but they are examining storage conditions as one possible cause. Warm weather or improper storage may lead to strips giving inaccurate reads.
The recall affects 359 batches of the strips marketed by Abbott Diabetes Care of California and are used with blood monitoring systems make by Abbott under the names Precision Xtra, ReliOn Ultima, Precision Xceed Pro, Optimum, Optimum EZ and MediSense Optium.
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