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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device azo dye, calcium
Regulation Description Calcium test system.
Product CodeCJY
Regulation Number 862.1145
Device Class 2


Premarket Reviews
ManufacturerDecision
ABBOTT
  SUBSTANTIALLY EQUIVALENT 3
Diagnostic Chemicals Ltd.
  SUBSTANTIALLY EQUIVALENT 1
OLYMPUS
  SUBSTANTIALLY EQUIVALENT 1
ORTHO-CLINICAL
  SUBSTANTIALLY EQUIVALENT 2
ROCHE DIAGNOSTICS CORP.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Low test results 9
Incorrect or inadequate test results 7
High test results 7
High Readings 1
No Known Device Problem 1
Mechanical issue 1
Output, high 1
Probe failure 1
Incorrect or inadequate result 1
Total Device Problems 29

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 2 1 0 1
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Ortho-Clinical Diagnostics II Jul-23-2016
2 Ortho-Clinical Diagnostics II Nov-15-2013
3 SEPPIM SAS II Nov-07-2013
4 Vital Diagnostics, Inc. II Jan-14-2014

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