Company: Nipro Diganostics
Date of Enforcement Report:1/6/2014
Class lI:
PRODUCT
TRUEbalance and TRUEtrack blood glucose meters distributed in the U.S., Europe, Asia and Canada, the company said Thursday.
REASON
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..
RECALLING FIRM/MANUFACTURER
Nipro Diagnostics, Ft Lauderdale, LF on 1/6/2014 Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
DISTRIBUTION
Nationwide
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