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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device counter, differential cell
Regulation Description Automated differential cell counter.
Product CodeGKZ
Regulation Number 864.5220
Device Class 2


Premarket Reviews
ManufacturerDecision
ABBOTT
  SUBSTANTIALLY EQUIVALENT 24
  SUBSTANTIALLY EQUIVALENT - CLIA SUBMISSION 3
BAYER
  SUBSTANTIALLY EQUIVALENT 5
BD
  SUBSTANTIALLY EQUIVALENT 9
  SUBSTANTIALLY EQUIVALENT - CLIA SUBMISSION 2
BECKMAN COULTER
  SUBSTANTIALLY EQUIVALENT 18
  SUBSTANTIALLY EQUIVALENT - CLIA SUBMISSION 4
INSTRUMENTATION LABORATORY
  SUBSTANTIALLY EQUIVALENT 1
KULZER
  SUBSTANTIALLY EQUIVALENT 3
NOVA
  SUBSTANTIALLY EQUIVALENT 1
ROCHE DIAGNOSTICS CORP.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD
  SUBSTANTIALLY EQUIVALENT - CLIA SUBMISSION 2
SYSMEX
  SUBSTANTIALLY EQUIVALENT 11
  SUBSTANTIALLY EQUIVALENT - CLIA SUBMISSION 5
UNIPATH
  SUBSTANTIALLY EQUIVALENT 2

Device Problems
Contamination during use 403
High Readings 355
Other (for use when an appropriate device code cannot be identified) 235
Device displays error message 216
Incorrect or inadequate test results 205
High test results 146
Low test results 118
Syringe, defective 116
Sensor problems 92
Break 64
Component incompatible 49
Smoking 32
Device operates differently than expected 28
Malfunction 28
Fluid leak 27
Device alarm system issue 23
Incorrect or inadequate result 20
Unknown (for use when the device problem is not known) 19
Leak 13
Failure, intermittent 10
Failure to sense 10
Mechanical issue 9
Fire 9
Imprecision 8
No code available 8
Device inoperable 7
Naturally worn 7
Overfill 7
Low readings 7
Computer software issue 6
Display misread 5
Incorrect display 4
Installation-related problem 4
Improper or incorrect procedure or method 3
Spark 3
Repair 3
No Information 3
Use of Incorrect Control Settings 3
Use of Device Issue 3
Nonstandard device or device component 3
Shock, electrical 3
Dislodged or dislocated 2
Device Issue 2
Defective item 2
Device contamination with blood or blood product 2
Device stops intermittently 2
Material integrity issue 2
No Known Device Problem 2
Detachment of device component 2
Defective component 2
Device maintenance issue 2
Bent 2
Sticking 2
Electro-static discharge 1
Malposition of device 1
Spillage, accidental 1
Normal 1
Loose or intermittent connection 1
Heat 1
False alarm 1
Fitting problem 1
Air eliminator, defective 1
Crack 1
Incorrect device or component shipped 1
Device expiration issue 1
Electronic property issue 1
Output issue 1
Device emits odor 1
Patient Data Issue 1
Cut in material 1
Shelf life exceeded 1
Manufacturing or shipping issue associated with device 1
Error or warning message, failure to produce 1
Replace 1
Data Issue 1
Unintended system motion 1
Dissatisfaction 1
Issue with displayed error message 1
False reading from device non-compliance 1
Incorrect measurement 1
Air leak 1
Aspiration issue 1
Unintended collision 1
Alarm, failure of warning 1
Corrosion 1
Split 1
Protective measure issue 1
Delayed alarm 1
Disconnection 1
Burn of device or device component 1
Positioning Issue 1
Device clogged 1
Device sensing issue 1
Aspiration, incomplete 1
Misapplication 1
Total Device Problems 2380

Recalls
  2007 2008 2009 2010 2011 2012 2013
Class I 0 0 0 0 0 0 0
Class II 7 11 6 9 26 7 0
Class III 0 1 0 3 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Abbott Diagnostics Division, 5440 Patrick Henry Drive, Santa Clara, CA II Nov-29-2010
2 Abbott Laboratories II Apr-29-2011
3 Abbott Laboratories II Mar-18-2011
4 Abbott Laboratories II Mar-17-2011
5 Abbott Laboratories II Mar-17-2011
6 Abbott Laboratories II Mar-17-2011
7 Abbott Laboratories II Mar-11-2011
8 Abbott Laboratories II Feb-10-2011
9 Abbott Laboratories II Sep-14-2010
10 Abbott Laboratories II Sep-02-2010
11 Abbott Laboratories II May-20-2010
12 Abbott Laboratories II Oct-19-2009
13 Abbott Laboratories II May-22-2009
14 Abbott Laboratories II Apr-23-2009
15 Abbott Laboratories II Apr-10-2009
16 Abbott Laboratories II Nov-21-2008
17 Abbott Laboratories II Aug-21-2008
18 Abbott Laboratories II Apr-24-2008
19 Abbott Laboratories II Mar-13-2008
20 Abbott Laboratories II Jan-04-2008
21 Abbott Laboratories II Aug-29-2007
22 Abbott Laboratories II Aug-18-2007
23 BD Biosciences II Aug-16-2008
24 BD Biosciences II Aug-08-2008
25 BD Biosciences II Mar-04-2008
26 BD Biosciences, Systems & Reagents II Sep-17-2012
27 BD Biosciences, Systems & Reagents II Mar-30-2011
28 BD Biosciences, Systems & Reagents II Nov-03-2010
29 BD Biosciences, Systems & Reagents II Jun-30-2010
30 BD Biosciences, Systems & Reagents III Apr-16-2010
31 Beckman Coulter Inc II Jan-13-2009
32 Beckman Coulter Inc II Jan-07-2009
33 Beckman Coulter Inc II Aug-08-2008
34 Beckman Coulter Inc II Jul-11-2008
35 Beckman Coulter Inc III Apr-30-2008
36 Beckman Coulter Inc II Feb-06-2008
37 Beckman Coulter Inc II Dec-22-2007
38 Beckman Coulter Inc II Mar-06-2007
39 Beckman Coulter Inc II Feb-08-2007
40 Beckman Coulter Inc. II Oct-10-2012
41 Beckman Coulter Inc. II Oct-09-2012
42 Beckman Coulter Inc. II Mar-21-2012
43 Beckman Coulter Inc. II Jan-11-2012
44 Beckman Coulter Inc. II Sep-01-2011
45 Beckman Coulter Inc. II May-20-2011
46 Beckman Coulter Inc. II May-10-2011
47 Beckman Coulter Inc. II May-09-2011
48 Beckman Coulter Inc. II May-05-2011
49 Beckman Coulter Inc. II May-05-2011
50 Beckman Coulter Inc. II May-02-2011
51 Beckman Coulter Inc. II Apr-29-2011
52 Beckman Coulter Inc. II Apr-29-2011
53 Beckman Coulter Inc. II Apr-20-2011
54 Beckman Coulter Inc. II Apr-14-2011
55 Beckman Coulter Inc. II Apr-14-2011
56 Beckman Coulter Inc. II Apr-13-2011
57 Beckman Coulter Inc. II Apr-12-2011
58 Beckman Coulter Inc. II Apr-04-2011
59 Beckman Coulter Inc. II Mar-18-2011
60 Beckman Coulter Inc. III Sep-01-2010
61 Beckman Coulter Inc. II Jun-25-2010
62 Beckman Coulter Inc. II May-26-2010
63 Beckman Coulter Inc. II May-26-2010
64 Beckman Coulter Inc. III May-26-2010
65 Drew Scientific Group PLC II Jan-09-2007
66 Drew Scientific Group PLC II Jan-05-2007
67 Pointcare Technologies, Inc. II Mar-08-2012
68 Siemens Medical Solutions USA, Inc. II Apr-06-2011
69 Sysmex America, Inc. II Nov-06-2012
70 Varian Medical Systems Oncology Systems II Jan-08-2011

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