Abbott Laboratories is recalling as many as 359 million blood glucose testing strips that could give false results to diabetics, the company and U.S. regulators said Wednesday.
Abbott said the strips -- used with its Precision Xtra, Precision Xceed Pro, MediSense Optium, Optium, OptiumEZ and ReliOn Ultima glucose monitoring systems -- should not be used and would be replaced at no cost.
The company said it expects little financial impact from the recall.
The move is not expected to impact the company's previously issued earnings estimate for 2010, company spokesman Scott Davies told Reuters. He added that the systems affected by the recall make up less than 5 percent of the U.S. market for glucose testing systems.
Shares of Abbott ended down 0.33 percent at $47.84 on the New York Stock Exchange on Wednesday, compared with a 0.1 percent rise of the Arca Pharmaceutical Index.
In a statement, Abbott said it uncovered the problem after a routine internal review found that certain lots of the strips took too long to absorb the blood from a patient's finger, which could lead to inaccurate low readings of their blood sugar levels.
That could cause patients to try to boost their blood sugar unnecessarily, it said.
The U.S. Food and Drug Administration, in a separate statement, said it was working with Abbott on the recall.
"FDA and Abbott are reviewing the cause of the manufacturing defect to avoid this problem in the future," Alberto Gutierrez, head of FDA's Office of In Vitro Diagnostics, said in a statement.
Affected strips were made between January and May and sold both to consumers and healthcare facilities, the FDA said, adding that exposure of the strips to heat or prolonged storage could also be an issue.
Abbott added that the monitoring systems themselves are not affected by the recall.
