Company: Nipro Diganostics
Date of Enforcement Report:1/6/2014
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..
Nipro Diagnostics, Ft Lauderdale, LF on 1/6/2014 Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE