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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device electrode measurement, blood-gases (pco2, po2) and blood ph
Regulation Description Blood gases (PCO2, PO2) and blood pH test system.
Product CodeCHL
Regulation Number 862.1120
Device Class 2


Premarket Reviews
ManufacturerDecision
3M COMPANY
  SUBSTANTIALLY EQUIVALENT 1
BAYER
  SUBSTANTIALLY EQUIVALENT 1
  SUBSTANTIALLY EQUIVALENT - CLIA SUBMISSION 1
BIONOSTICS, INC.
  SUBSTANTIALLY EQUIVALENT 2
INSTRUMENTATION LABORATORY
  SUBSTANTIALLY EQUIVALENT 11
I-STAT
  SUBSTANTIALLY EQUIVALENT 3
NOVA
  SUBSTANTIALLY EQUIVALENT 16
  SUBSTANTIALLY EQUIVALENT - CLIA SUBMISSION 5
RADIOMETER
  SUBSTANTIALLY EQUIVALENT 8
  SUBSTANTIALLY EQUIVALENT - CLIA SUBMISSION 2
ROCHE DIAGNOSTICS CORP.
  SUBSTANTIALLY EQUIVALENT 1
  SUBSTANTIALLY EQUIVALENT - CLIA SUBMISSION 1
SENDX MEDICAL
  SUBSTANTIALLY EQUIVALENT 2
  SUBSTANTIALLY EQUIVALENT - CLIA SUBMISSION 1

Device Problems
Low test results 12
Incorrect or inadequate test results 11
High test results 7
Burn of device or device component 3
Device Cleaning Issue 2
Use of Device Issue 2
Incorrect or inadequate result 2
Inadequate service 1
Device inoperable 1
Device operates differently than expected 1
Data Issue 1
Device alarm system issue 1
Valve(s), failure of 1
Blood gas measurements, erroneous 1
Failure to calibrate 1
Computer software issue 1
Electrical issue 1
Leak 1
Total Device Problems 50

Recalls
  2007 2008 2009 2010 2011 2012 2013
Class I 0 0 0 0 0 0 0
Class II 6 0 2 3 3 8 0
Class III 1 0 1 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Abbott Point Of Care Inc. II Aug-02-2012
2 Abbott Point Of Care Inc. II Jul-09-2012
3 Abbott Point Of Care Inc. II Mar-10-2011
4 Abbott Point Of Care Inc. II Dec-10-2010
5 Abbott Point Of Care Inc. II Nov-03-2010
6 Abbott Point of Care Inc. II Jan-20-2011
7 Abbott Point of Care Inc. III Jun-18-2009
8 Instrumentation Laboratory Co. II Jun-27-2011
9 Instrumentation Laboratory Co. II May-03-2007
10 OPTI Medical Systems, Inc II Sep-21-2012
11 Radiometer America Inc II Aug-08-2012
12 Radiometer America Inc II Jul-15-2009
13 Radiometer America Inc II Oct-11-2007
14 Radiometer America Inc III Jul-24-2007
15 Radiometer America Inc II Apr-06-2007
16 Roche Diagnostics Operations, Inc. II Dec-13-2012
17 Sendx Medical Inc II Nov-05-2012
18 Sendx Medical Inc II Aug-30-2012
19 Sendx Medical Inc II Apr-09-2012
20 Sendx Medical Inc II Nov-10-2009
21 Sendx Medical Inc II Aug-29-2007
22 Sendx Medical Inc II Aug-25-2007
23 Sendx Medical Inc II Aug-18-2007
24 Siemens Healthcare Diagnostics Inc II Mar-16-2010

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