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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device station, pipetting and diluting, for clinical use
Regulation Description Pipetting and diluting system for clinical use.
Product CodeJQW
Regulation Number 862.2750
Device Class 1


Premarket Reviews
ManufacturerDecision
ABBOTT
  SUBSTANTIALLY EQUIVALENT 3
BAXTER HEALTHCARE CORP.
  SUBSTANTIALLY EQUIVALENT 2
BD
  SUBSTANTIALLY EQUIVALENT 1
Bio-Rad Laboratories
  SUBSTANTIALLY EQUIVALENT 1
DIAGNOSTIC PRODUCTS
  SUBSTANTIALLY EQUIVALENT 5
HAMILTON
  SUBSTANTIALLY EQUIVALENT 6
INSTRUMENTATION LABORATORY
  SUBSTANTIALLY EQUIVALENT 2
Nichols Institute Diagnostics
  SUBSTANTIALLY EQUIVALENT 1
ORGANON-TEKNIKA
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Malfunction 10
Device handling issue 6
Computer software issue 6
Use of Device Issue 5
Other (for use when an appropriate device code cannot be identified) 4
False positive result 3
Component(s), broken 3
Component falling 3
Low test results 3
Device displays error message 2
Material integrity issue 2
Component(s), worn 2
Device maintenance issue 2
Inadequate service 2
Unknown (for use when the device problem is not known) 2
Vacuum, loss of 1
Improper or incorrect procedure or method 1
Smoking 1
Syringe, defective 1
Fracture 1
Mechanical issue 1
Mislabeled 1
Unintended system motion 1
Sensor problems 1
Error or warning message, failure to produce 1
False negative result 1
No code available 1
Sharp/jagged/rough/etched/scratched 1
Low readings 1
Defective item 1
Break 1
Total Device Problems 71

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 1 2 0 1 2 3 1 1 2 0
Class III 0 0 0 0 1 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Abbott Molecular II Jul-14-2012
2 BD Biosciences, Systems & Reagents II Jun-25-2015
3 Beckman Coulter Inc II Dec-16-2008
4 Beckman Coulter Inc. II Jun-26-2015
5 Beckman Coulter Inc. II Oct-12-2012
6 Beckman Coulter Inc. II Oct-01-2012
7 Beckman Coulter Inc. II Oct-07-2011
8 Beckman Coulter Inc. II Jun-04-2010
9 Bio-Rad Laboratories Inc III Mar-02-2011
10 Bio-Rad Laboratories, Inc. II Mar-18-2011
11 Hamilton Co II Sep-17-2008
12 Hamilton Co II Aug-16-2007
13 Tecan US, Inc. II Oct-29-2014
14 Tecan US, Inc. II Jun-19-2013

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