Fort Lauderdale, Fla.-based Nipro Diagnostics is voluntarily recalling certain TRUEbalance and TRUEtrack blood glucose meters distributed in the U.S., Europe, Asia and Canada, the company said Thursday.
The affected meters — 501 TRUEbalance and 105 TRUEtrack — may have a flaw in the factory-set unit of measure that would cause them to measure blood sugar in mmol/L rather than mg/dL, potentially leading to a too-low reading. The devices in the U.S. were distributed between September 2008 and May 2009.
While there have been no reports of adverse events related to the error, Nipro is working with affiliates and regulatory agencies to better understand and identify affected products and resolve the issue, spokeswoman Lisa Nardi said.
Nipro is advising patients with either device to enter the serial number on the company website and, if the unit is part of the recall, request a replacement at no additional cost. — Lena Freund
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