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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device method, enzymatic, glucose (urinary, non-quantitative)
Regulation Description Urinary glucose (nonquantitative) test system.
Product CodeJIL
Regulation Number 862.1340
Device Class 2


Premarket Reviews
ManufacturerDecision
  SUBSTANTIALLY EQUIVALENT 1
ARKRAY USA, INC.
  SUBSTANTIALLY EQUIVALENT 2
BAYER
  SUBSTANTIALLY EQUIVALENT 1
BOEHRINGER
  SUBSTANTIALLY EQUIVALENT 2
HYPOGUARD, LTD.
  SUBSTANTIALLY EQUIVALENT 2
ROCHE DIAGNOSTICS CORP.
  SUBSTANTIALLY EQUIVALENT 2

Device Problems
False negative result 57
Low test results 16
Incorrect or inadequate test results 10
Incorrect or inadequate result 6
Smoking 3
Failure to run on AC/DC 3
False positive result 2
Mechanical issue 2
Output, low 2
Computer operating system issue 2
Power source issue 2
Programming issue 1
Data Issue 1
Patient Data Issue 1
Device operates differently than expected 1
Failure to power-up 1
Normal 1
Device displays error message 1
Spark 1
Buckled material 1
False reading from device non-compliance 1
Fire 1
Fluid leak 1
Leak 1
Device maintenance issue 1
Device clogged 1
False device output 1
Total Device Problems 121

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
Class I 0 0 0 0 0 0 0 0 0 0
Class II 0 0 0 0 0 0 0 1 0 2
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Beckman Coulter Inc. II Jan-13-2016
2 Roche Diagnostics Operations, Inc. II Oct-25-2016
3 Siemens Healthcare Diagnostics, Inc II Oct-17-2014

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