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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 2
BIONOSTICS, INC.
  SUBSTANTIALLY EQUIVALENT 2
EDAN INSTRUMENTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
INSTRUMENTATION LABORATORY
  SUBSTANTIALLY EQUIVALENT 12
I-STAT
  SUBSTANTIALLY EQUIVALENT 3
NOVA
  SUBSTANTIALLY EQUIVALENT 25
RADIOMETER
  SUBSTANTIALLY EQUIVALENT 14
ROCHE DIAGNOSTICS CORP.
  SUBSTANTIALLY EQUIVALENT 2
SENDX MEDICAL
  SUBSTANTIALLY EQUIVALENT 3

Device Problems
Low test results 33
High test results 21
Incorrect or inadequate test results 20
Incorrect or inadequate result 15
Use of Device Issue 7
Device handling issue 5
No Known Device Problem 3
Burn of device or device component 3
Leak 3
Fluid leak 2
Device Cleaning Issue 2
Data Issue 2
Low readings 2
Device operates differently than expected 1
Patient Data Issue 1
Computer software issue 1
Electrical issue 1
False reading from device non-compliance 1
Device alarm system issue 1
Product quality issue 1
Valve(s), failure of 1
Blood gas measurements, erroneous 1
Failure to calibrate 1
Inadequate service 1
Device inoperable 1
Total Device Problems 130

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 6 0 2 3 3 8 1 3 5 2
Class III 1 0 1 0 0 0 0 1 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Abbott Point Of Care Inc. II Mar-27-2014
2 Abbott Point Of Care Inc. II Aug-02-2012
3 Abbott Point Of Care Inc. II Jul-09-2012
4 Abbott Point Of Care Inc. II Mar-10-2011
5 Abbott Point Of Care Inc. II Dec-10-2010
6 Abbott Point Of Care Inc. II Nov-03-2010
7 Abbott Point of Care Inc. II Jan-20-2011
8 Abbott Point of Care Inc. III Jun-18-2009
9 Instrumentation Laboratory Co. II Jun-27-2011
10 Instrumentation Laboratory Co. II May-03-2007
11 LifeHealth, LLC II Oct-23-2015
12 LifeHealth, LLC II Jun-27-2015
13 OPTI Medical Systems, Inc II Sep-21-2012
14 Radiometer America Inc II Feb-03-2016
15 Radiometer America Inc II Jun-25-2015
16 Radiometer America Inc II Feb-24-2014
17 Radiometer America Inc II Jan-10-2014
18 Radiometer America Inc II Aug-08-2012
19 Radiometer America Inc II Jul-15-2009
20 Radiometer America Inc II Oct-11-2007
21 Radiometer America Inc III Jul-24-2007
22 Radiometer America Inc II Apr-06-2007
23 Roche Diagnostics Operations, Inc. II Aug-21-2015
24 Roche Diagnostics Operations, Inc. II Aug-05-2015
25 Roche Diagnostics Operations, Inc. III Oct-10-2014
26 Roche Diagnostics Operations, Inc. II Dec-13-2012
27 Sendx Medical Inc II Nov-05-2012
28 Sendx Medical Inc II Aug-30-2012
29 Sendx Medical Inc II Apr-09-2012
30 Sendx Medical Inc II Nov-10-2009
31 Sendx Medical Inc II Aug-29-2007
32 Sendx Medical Inc II Aug-25-2007
33 Sendx Medical Inc II Aug-18-2007
34 Siemens Healthcare Diagnostics Inc II Sep-14-2016
35 Siemens Healthcare Diagnostics Inc II Oct-29-2013
36 Siemens Healthcare Diagnostics Inc II Mar-08-2010

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