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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device reagent, general purpose
Regulation Description General purpose reagent.
Product CodeLDT
Regulation Number 864.4010
Device Class 1

Device Problems
Leak 1
Contamination of device ingredient or reagent 1
Device emits odor 1
Imprecision 1
Device Cleaning Issue 1
High test results 1
Use of Device Issue 1
Failure to calibrate 1
Total Device Problems 8

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

Recalls
Manufacturer Recall Class Date Posted
1 Beckman Coulter Inc. II Apr-20-2011
2 Celera Corporation III Aug-26-2013
3 Dako North America Inc. II Nov-05-2015

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