US drug maker Abbott Laboratories on Wednesday, December 22 announced a recall of up to 359 million diabetes testing strips due to safety hazards.
The recall was initiated because the strips used by diabetics could give false low readings, the company said in a statement.
Abbott 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, the statement said.
The affected products should not be used and would be replaced at no cost, said the statement.
Meanwhile, the Food and Drug Administration (FDA) issued a warning that inaccurately low measurements by the strips may lead patients to raise their blood sugar levels unnecessarily or fail to detect dangerously high blood sugar levels.
The recalled strips were made between January and May and sold both to consumers and healthcare facilities, the FDA said.
“FDA and Abbott are reviewing the cause of the manufacturing defect to avoid this problem in the future,” said Alberto Gutierrez, head of FDA’s Office of In Vitro Diagnostics.
The lots of affected products were only distributed in the U.S. and Puerto Rico, according to Greg Miley, director of public affairs for Abbott Diabetes Care.
The products were marketed under a half-dozen brand names, including Precision Xceed Pro., Precision Xtra, Medisense Optium, Optium, OptiumEZ and ReliOn Ultima, the Abbott statement said.