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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device phosphomolybdate (colorimetric), inorganic phosphorus
Regulation Description Phosphorus (inorganic) test system.
Product CodeCEO
Regulation Number 862.1580
Device Class 1


Premarket Reviews
ManufacturerDecision
ABBOTT
  SUBSTANTIALLY EQUIVALENT 4
BAXTER HEALTHCARE CORP.
  SUBSTANTIALLY EQUIVALENT 1
BECKMAN COULTER
  SUBSTANTIALLY EQUIVALENT 1
BOEHRINGER
  SUBSTANTIALLY EQUIVALENT 1
Diagnostic Chemicals Ltd.
  SUBSTANTIALLY EQUIVALENT 1
EASTMAN KODAK
  SUBSTANTIALLY EQUIVALENT 2
EMD
  SUBSTANTIALLY EQUIVALENT 2
INSTRUMENTATION LABORATORY
  SUBSTANTIALLY EQUIVALENT 2
MEDICAL SPECIALTIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
OLYMPUS
  SUBSTANTIALLY EQUIVALENT 1
ROCHE DIAGNOSTICS CORP.
  SUBSTANTIALLY EQUIVALENT 1
TRACE SCIENTIFIC LTD.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Unknown (for use when the device problem is not known) 13
High test results 5
Low test results 3
Incorrect or inadequate test results 2
No Known Device Problem 1
Total Device Problems 24

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 0 0 1 0 0 4 0 0 0
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Abbott Laboratories Inc. II Sep-10-2010
2 Abbott Laboratories Inc. II Apr-05-2007
3 Abbott Laboratories, Inc II Oct-17-2013
4 Alfa Wassermann, Inc. II Jan-28-2013
5 Ortho-Clinical Diagnostics II Nov-15-2013
6 Siemens Healthcare Diagnostics, Inc. II Apr-02-2013

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