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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device manual antimicrobial susceptibility test systems
Regulation Description Antimicrobial susceptibility test powder.
Product CodeJWY
Regulation Number 866.1640
Device Class 2


Premarket Reviews
ManufacturerDecision
BAXTER HEALTHCARE CORP.
  SUBSTANTIALLY EQUIVALENT 7
BD
  SUBSTANTIALLY EQUIVALENT 6
BECKMAN COULTER
  SUBSTANTIALLY EQUIVALENT 1
BIOMERIEUX
  SUBSTANTIALLY EQUIVALENT 2
DADE
  SUBSTANTIALLY EQUIVALENT 26
DADE BEHRING
  SUBSTANTIALLY EQUIVALENT 8
FISHER SCIENTIFIC
  SUBSTANTIALLY EQUIVALENT 12
MEDICAL SPECIALTIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
MICROTEK MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 5
SIEMENS
  SUBSTANTIALLY EQUIVALENT 1
Trek Diagnostic Systems
  SUBSTANTIALLY EQUIVALENT 46

Device Problems
Incorrect or inadequate result 21
Low readings 3
Device inoperable 2
Low test results 2
High Readings 2
Incorrect or inadequate test results 1
No Known Device Problem 1
No code available 1
False positive result 1
Total Device Problems 34

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
Class I 0 0 0 0 0 0 0 0 1 0
Class II 0 0 1 0 0 1 1 1 5 0
Class III 0 0 0 0 0 0 0 1 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Beckman Coulter, Inc. II Apr-27-2015
2 Beckman Coulter, Inc. II Apr-27-2015
3 Beckman Coulter, Inc. II Apr-26-2015
4 Becton Dickinson & Co. II Dec-23-2015
5 Becton Dickinson & Co. II Sep-12-2014
6 Becton Dickinson & Co. II Jul-24-2013
7 BioMerieux SA II Jul-01-2015
8 Biomerieux I Dec-23-2015
9 Biomerieux III Nov-19-2014
10 Siemens Healthcare Diagnostics, Inc. II May-08-2012
11 Siemens Microscan II Feb-04-2009

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