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TPLC
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show TPLC since
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Device
radioimmunoassay, estradiol
Product Code
CHP
Regulation Number
862.1260
Device Class
1
MDR Year
MDR Reports
MDR Events
2014
12
12
2015
18
18
2016
29
29
2017
39
39
2018
38
38
2019
36
39
2020
135
135
2021
43
43
2022
61
61
2023
60
60
2024
46
46
Device Problems
MDRs with this Device Problem
Events in those MDRs
High Test Results
241
244
Low Test Results
122
122
Incorrect, Inadequate or Imprecise Result or Readings
79
79
Non Reproducible Results
59
59
Adverse Event Without Identified Device or Use Problem
27
27
Incorrect Or Inadequate Test Results
18
18
Incorrect Measurement
17
17
No Apparent Adverse Event
14
14
Calibration Problem
6
6
Low Readings
3
3
False Reading From Device Non-Compliance
3
3
High Readings
2
2
Appropriate Term/Code Not Available
2
2
Device Damaged Prior to Use
2
2
Insufficient Information
1
1
Manufacturing, Packaging or Shipping Problem
1
1
Material Integrity Problem
1
1
Defective Device
1
1
Unable to Obtain Readings
1
1
Failure to Calibrate
1
1
Mechanical Problem
1
1
Output Problem
1
1
Device Markings/Labelling Problem
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Known Impact Or Consequence To Patient
195
198
No Clinical Signs, Symptoms or Conditions
170
170
No Consequences Or Impact To Patient
62
62
No Code Available
41
41
Insufficient Information
35
35
Misdiagnosis
7
7
Overdose
4
4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
2
2
Therapeutic Response, Increased
2
2
No Patient Involvement
2
2
Death
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Abbott Ireland Diagnostics Division
II
May-16-2019
2
Abbott Ireland Diagnostics Division
II
Dec-22-2018
3
Abbott Laboratories
II
May-31-2016
4
Beckman Coulter Inc.
II
Nov-23-2010
5
BioMerieux SA
II
Mar-20-2017
6
Biomerieux Inc
II
Jan-04-2023
7
Diasorin Inc.
II
Nov-21-2016
8
ORTHO-CLINICAL DIAGNOSTICS
II
Aug-05-2016
9
Roche Diagnostics Operations, Inc.
II
Mar-31-2016
10
Siemens Healthcare Diagnostics, Inc
II
Feb-04-2018
11
Siemens Healthcare Diagnostics, Inc
II
Mar-24-2016
12
Siemens Healthcare Diagnostics, Inc.
II
Apr-29-2022
13
Siemens Healthcare Diagnostics, Inc.
II
Feb-24-2020
14
Siemens Healthcare Diagnostics, Inc.
II
Jul-13-2018
15
Siemens Healthcare Diagnostics, Inc.
II
May-05-2017
16
Tosoh Bioscience Inc
II
Jun-05-2018
17
bioMerieux, Inc.
II
Dec-28-2021
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