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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 13
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
Incorrect or inadequate result 49
Low test results 38
High test results 35
Incorrect or inadequate test results 31
Use of Device Issue 26
False positive result 14
Fluid leak 9
Leak 5
No Known Device Problem 5
Device handling issue 5
Burn of device or device component 3
Electrical issue 3
Computer software issue 2
Device Cleaning Issue 2
Mechanical issue 2
Output issue 2
Data Issue 2
Patient Data Issue 2
Low readings 2
Improper or incorrect procedure or method 2
Device Issue 2
Device operates differently than expected 2
Improper device output 1
Failure to calibrate 1
Device alarm system issue 1
Blood gas measurements, erroneous 1
Device contamination with blood or blood product 1
Valve(s), failure of 1
Device displays error message 1
Calibration issue 1
High Readings 1
Product quality issue 1
Inadequate service 1
Device inoperable 1
Incorrect measurement 1
False reading from device non-compliance 1
Coagulation in device or device ingredient 1
Calibration error 1
Use of Incorrect Control Settings 1
Degraded 1
False negative result 1
Total Device Problems 262

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
Class I 0 0 0 0 0 0 0 0 0 0 0
Class II 6 0 2 3 3 8 1 3 5 3 4
Class III 1 0 1 0 0 0 0 1 0 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 Nova Biomedical Corporation II Jul-13-2017
14 OPTI Medical Systems, Inc II Sep-21-2012
15 Radiometer America Inc II Mar-14-2017
16 Radiometer America Inc II Dec-22-2016
17 Radiometer America Inc II Feb-03-2016
18 Radiometer America Inc II Jun-25-2015
19 Radiometer America Inc II Feb-24-2014
20 Radiometer America Inc II Jan-10-2014
21 Radiometer America Inc II Aug-08-2012
22 Radiometer America Inc II Jul-15-2009
23 Radiometer America Inc II Oct-11-2007
24 Radiometer America Inc III Jul-24-2007
25 Radiometer America Inc II Apr-06-2007
26 Roche Diagnostics Operations, Inc. II Jan-23-2017
27 Roche Diagnostics Operations, Inc. II Aug-21-2015
28 Roche Diagnostics Operations, Inc. II Aug-05-2015
29 Roche Diagnostics Operations, Inc. III Oct-10-2014
30 Roche Diagnostics Operations, Inc. II Dec-13-2012
31 Sendx Medical Inc II Nov-05-2012
32 Sendx Medical Inc II Aug-30-2012
33 Sendx Medical Inc II Apr-09-2012
34 Sendx Medical Inc II Nov-10-2009
35 Sendx Medical Inc II Aug-29-2007
36 Sendx Medical Inc II Aug-25-2007
37 Sendx Medical Inc II Aug-18-2007
38 Siemens Healthcare Diagnostics Inc II May-05-2017
39 Siemens Healthcare Diagnostics Inc II Sep-14-2016
40 Siemens Healthcare Diagnostics Inc II Oct-29-2013
41 Siemens Healthcare Diagnostics Inc II Mar-08-2010

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