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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device colorimeter, photometer, spectrophotometer for clinical use
Regulation Description Colorimeter, photometer, or spectrophotometer for clinical use.
Product CodeJJQ
Regulation Number 862.2300
Device Class 1


Premarket Reviews
ManufacturerDecision
ABBOTT
  SUBSTANTIALLY EQUIVALENT 9
BAUSCH & LOMB, INC.
  SUBSTANTIALLY EQUIVALENT 6
Bio-Rad Laboratories
  SUBSTANTIALLY EQUIVALENT 1
BOEHRINGER
  SUBSTANTIALLY EQUIVALENT 4
DIGENE CORP.
  SUBSTANTIALLY EQUIVALENT 1
DOW
  SUBSTANTIALLY EQUIVALENT 2
EASTMAN KODAK
  SUBSTANTIALLY EQUIVALENT 1
EMD
  SUBSTANTIALLY EQUIVALENT 1
HAMILTON
  SUBSTANTIALLY EQUIVALENT 1
INSTRUMENTATION LABORATORY
  SUBSTANTIALLY EQUIVALENT 4
JOHNSON & JOHNSON
  SUBSTANTIALLY EQUIVALENT 1
KULZER
  SUBSTANTIALLY EQUIVALENT 2
Nichols Institute Diagnostics
  SUBSTANTIALLY EQUIVALENT 1
OHMEDA MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
OLYMPUS
  SUBSTANTIALLY EQUIVALENT 1
QUIDEL CORP.
  SUBSTANTIALLY EQUIVALENT 1
ROCHE DIAGNOSTICS CORP.
  SUBSTANTIALLY EQUIVALENT 3
  1.  K881877  COBAS EIA(TM) PHOTOMETER
  2.  K896007  COBAS READY
  3.  K921180  COBAS CORE IMMUNOCHEMISTRY SYSTEM
TERUMO CARDIOVASCULAR SYSTEMS
  SUBSTANTIALLY EQUIVALENT 2
TOSOH CORP.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Smoking 8
No Known Device Problem 6
Mechanical issue 3
Other (for use when an appropriate device code cannot be identified) 2
No Information 2
Incorrect or inadequate test results 1
High test results 1
Low test results 1
Low readings 1
Defective item 1
Calibration issue 1
Electrical issue 1
Use of Device Issue 1
Total Device Problems 29

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
Class I 0 0 0 0 0 0 0 0 0 0 0
Class II 0 1 2 0 0 0 0 0 1 1 0
Class III 0 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 BioTek Instruments, Inc. II Sep-18-2009
2 Diasorin Inc. II Mar-30-2009
3 Otsuka America Pharmaceutical, Inc. II Sep-01-2008
4 QIAGEN Gaithersburg, Inc. II Jun-26-2015
5 Tecan US, Inc. II Aug-25-2016

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