Analyzer, Chemistry (photometric, Discrete), For Clinical Use

Device Code: 452

Product Code(s): JJE

Device Classification Information

Device Type ID452
Device NameAnalyzer, Chemistry (photometric, Discrete), For Clinical Use
Regulation DescriptionDiscrete Photometric Chemistry Analyzer For Clinical Use.
Regulation Medical SpecialtyClinical Chemistry
Review PanelClinical Chemistry
Premarket Review Office Of In Vitro Diagnostics And Radiological Health (OIR)
Submission Type510(K) Exempt
CFR Regulation Number862.2160 [🔎]
FDA Device ClassificationClass 1 Medical Device
Product CodeJJE
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID452
DeviceAnalyzer, Chemistry (photometric, Discrete), For Clinical Use
Product CodeJJE
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionDiscrete Photometric Chemistry Analyzer For Clinical Use.
CFR Regulation Number862.2160 [🔎]
Premarket Reviews
ManufacturerDecision
CORPORATE HEADQUARTERS, CAROLINA LIQUID CHEMISTRIES, CORP.
 
SUBSTANTIALLY EQUIVALENT
 1
JAS DIAGNOSTICS, INC.
 
SUBSTANTIALLY EQUIVALENT
 1
Device Problems
Low Test Results
 2988
High Test Results
 2679
Mechanical Problem
 1802
Adverse Event Without Identified Device Or Use Problem
 1077
Incorrect Or Inadequate Test Results
 903
Non Reproducible Results
 626
Probe
 453
Tube
 401
Patient Data Problem
 350
Incorrect, Inadequate Or Imprecise Result Or Readings
 326
Leak / Splash
 225
Fluid Leak
 205
Device Issue
 192
Valve
 121
Nozzle
 116
Cell
 113
Pump
 96
Insufficient Information
 96
Device Operates Differently Than Expected
 86
False Positive Result
 84
Device Subassembly
 81
Washer
 75
Smoking
 69
Low Readings
 68
Mixer
 61
High Readings
 58
Seal
 52
Device Operational Issue
 52
Power Problem
 49
Thermal Decomposition Of Device
 48
Charred
 45
Electrical /Electronic Property Problem
 37
False Negative Result
 35
Missing Value Reason
 32
Device Handling Problem
 31
Appropriate Term/Code Not Available
 31
Syringe
 29
Electrode
 28
Filter
 27
Cover
 25
Device Component Or Accessory
 25
PC (Printed Circuit) Board
 23
Computer Software Problem
 23
Device Displays Incorrect Message
22
Diaphragm
 21
Lamp
 20
Imprecision
20
Labelling, Instructions For Use Or Training Problem
 18
Electrical Shorting
 18
Human Factors Issue
 18
Use Of Device Problem
 18
Cable
 17
Sparking
 17
Unable To Obtain Readings
17
Holder
 16
Screw
 16
Reservoir
 14
Cups
 13
Fire
 12
Calibration Problem
 12
Overheating Of Device
 11
Device Ingredient Or Reagent
 11
Photomultiplier (PM) Tube
 11
Melted
 11
Ring
 10
Spring
 10
Power Supply
 9
Failure To Calibrate
 8
Connector
 8
Belt
 7
Loose Or Intermittent Connection
 7
Unintended Movement
 7
Gauges/Meters
 7
Mechanism
 7
Obstruction Of Flow
 6
Partial Blockage
 6
Pumping Problem
 6
Sensor
 6
Needle
 6
Delivery System Failure
 5
Component Falling
 5
Clip
 5
Device Emits Odor
 5
Contamination Of Device Ingredient Or Reagent
 5
Arcing
 5
No Apparent Adverse Event
 5
Defective Component
 5
Circuit Board
 5
Human-Device Interface Problem
 5
Nuts
 5
Communication Or Transmission Problem
 4
Inappropriate Shock
 4
Device Contamination With Body Fluid
 4
Incorrect Measurement
 4
Wire
 4
Nozzle Tip
 4
Cooling Module
 4
Guide
 4
Joint
 4
Motor
 4
Total Device Problems 14481
Recalls
Manufacturer Recall Class Date Posted
1
Abbott Gmbh & Co. KG
 II Jan-30-2019
2
Abbott Laboratories
 II Jul-22-2015
3
Abbott Laboratories
 II Jun-08-2015
4
Abbott Laboratories, Inc
 II Jan-18-2018
5
Abbott Laboratories, Inc
 II Nov-21-2017
6
Abbott Laboratories, Inc
 II Oct-06-2017
7
Abbott Laboratories, Inc
 II Oct-26-2015
8
Beckman Coulter Inc.
 II Mar-30-2019
9
Beckman Coulter Inc.
 II Oct-11-2018
10
Beckman Coulter Inc.
 III Jan-03-2018
11
Beckman Coulter Inc.
 II Oct-24-2017
12
Beckman Coulter Inc.
 II Apr-03-2017
13
Beckman Coulter Inc.
 II Mar-15-2017
14
Beckman Coulter Inc.
 II Aug-01-2016
15
Beckman Coulter Inc.
 II Jul-22-2016
16
Beckman Coulter Inc.
 II Nov-06-2014
17
Beckman Coulter Inc.
 II Sep-23-2014
18
Beckman Coulter Inc.
 II Jun-09-2014
19
Beckman Coulter Inc.
 II Feb-16-2014
20
Bio-Rad Laboratories Inc
 II Jul-25-2018
21
Bio-Rad Laboratories, Inc.
 II Feb-13-2016
22
Horiba Instruments Inc
 II Apr-22-2016
23
Horiba Instruments, Inc Dba Horiba Medical
 II Jan-31-2018
24
Horiba Instruments, Inc Dba Horiba Medical
 II Jan-02-2015
25
Inova Diagnostics Incorporated
 II Mar-27-2018
26
Ortho-Clinical Diagnostics
 II Dec-20-2018
27
Ortho-Clinical Diagnostics
 II Dec-14-2017
28
Ortho-Clinical Diagnostics
 II May-12-2017
29
Ortho-Clinical Diagnostics
 II Oct-22-2016
30
Ortho-Clinical Diagnostics
 III Jul-08-2016
31
Ortho-Clinical Diagnostics
 II Jun-06-2016
32
Ortho-Clinical Diagnostics
 II Apr-26-2016
33
Ortho-Clinical Diagnostics
 II Apr-07-2016
34
Ortho-Clinical Diagnostics
 II Mar-08-2016
35
Ortho-Clinical Diagnostics
 II Jan-13-2016
36
Ortho-Clinical Diagnostics
 II Nov-05-2015
37
Ortho-Clinical Diagnostics
 II Sep-02-2015
38
Ortho-Clinical Diagnostics
 II Jun-26-2015
39
Ortho-Clinical Diagnostics
 II Jun-09-2015
40
Ortho-Clinical Diagnostics
 II Jun-08-2015
41
Ortho-Clinical Diagnostics
 II Jun-08-2015
42
Ortho-Clinical Diagnostics
 II Apr-25-2015
43
Ortho-Clinical Diagnostics
 III Jan-20-2015
44
Ortho-Clinical Diagnostics
 II Jan-14-2015
45
Ortho-Clinical Diagnostics
 II Oct-16-2014
46
Ortho-Clinical Diagnostics
 II Aug-01-2014
47
Ortho-Clinical Diagnostics
 II Jun-10-2014
48
Ortho-Clinical Diagnostics
 II Jun-09-2014
49
Ortho-Clinical Diagnostics
 II Jun-09-2014
50
Ortho-Clinical Diagnostics
 II Jun-02-2014
51
Ortho-Clinical Diagnostics
 II Apr-28-2014
52
Ortho-Clinical Diagnostics
 II Feb-09-2014
53
Radiometer America Inc
 II Oct-01-2018
54
Radiometer America Inc
 II Feb-09-2015
55
Randox Laboratories
 II Jun-04-2018
56
Roche Diagnostics Corporation
 II Jun-10-2018
57
Roche Diagnostics Corporation
 II Mar-28-2018
58
Roche Diagnostics Corporation
 II Mar-06-2018
59
Roche Diagnostics Corporation
 II Feb-21-2018
60
Roche Diagnostics Corporation
 II Feb-01-2018
61
Roche Diagnostics Corporation
 II Jan-16-2018
62
Roche Diagnostics Corporation
 II May-09-2017
63
Roche Diagnostics Operations, Inc.
 II Nov-10-2016
64
Roche Diagnostics Operations, Inc.
 II Oct-25-2016
65
Roche Diagnostics Operations, Inc.
 II Jun-27-2015
66
Roche Diagnostics Operations, Inc.
 II Jun-14-2014
67
Roche Diagnostics Operations, Inc.
 II Apr-10-2014
68
Siemens Healthcare Diagnostics
 II Sep-29-2014
69
Siemens Healthcare Diagnostics
 II Sep-18-2014
70
Siemens Healthcare Diagnostics
 II May-13-2014
71
Siemens Healthcare Diagnostics Inc.
 II Jun-01-2016
72
Siemens Healthcare Diagnostics Inc.
 II Dec-22-2015
73
Siemens Healthcare Diagnostics, Inc
 III Nov-14-2014
74
Siemens Healthcare Diagnostics, Inc
 II Jun-26-2014
75
Siemens Healthcare Diagnostics, Inc.
 II Mar-15-2019
76
Siemens Healthcare Diagnostics, Inc.
 II Dec-14-2018
77
Siemens Healthcare Diagnostics, Inc.
 II Nov-09-2018
78
Siemens Healthcare Diagnostics, Inc.
 II Oct-18-2018
79
Siemens Healthcare Diagnostics, Inc.
 II May-01-2018
80
Siemens Healthcare Diagnostics, Inc.
 II Mar-19-2017
81
Siemens Healthcare Diagnostics, Inc.
 II Feb-23-2017
82
Siemens Healthcare Diagnostics, Inc.
 II Nov-16-2016
83
Siemens Healthcare Diagnostics, Inc.
 III May-06-2016
84
Siemens Healthcare Diagnostics, Inc.
 II Feb-04-2016
85
Siemens Healthcare Diagnostics, Inc.
 II Jul-09-2015
86
Siemens Healthcare Diagnostics, Inc.
 II May-14-2015
87
Siemens Healthcare Diagnostics, Inc.
 II Dec-23-2014
88
Siemens Healthcare Diagnostics, Inc.
 II Dec-20-2014
89
Siemens Healthcare Diagnostics, Inc.
 II Aug-26-2014
90
Siemens Healthcare Diagnostics, Inc.
 III Jul-30-2014
91
Siemens Healthcare Diagnostics, Inc.
 II Jun-25-2014
92
Siemens Healthcare Diagnostics, Inc.
 II Jun-09-2014
93
Siemens Healthcare Diagnostics, Inc.
 II Feb-09-2014
94
Siemens Healthcare Diagnostics, Inc.
 II Jan-28-2014
95
Siemens Healthcare Diagnostics, Inc.
 II Jan-21-2014
96
Siemens Medical Solutions Diagnostics
 II May-23-2015
97
Siemens Medical Solutions Diagnostics
 II Apr-02-2014
98
The Binding Site Group, Ltd.
 II Jan-13-2017
99
bioMerieux, Inc.
 II Jul-31-2018
100
bioMerieux, Inc.
 II May-09-2018
TPLC Last Update: 2019-04-02 19:35:03
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