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TPLC
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show TPLC since
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Device
radioimmunoassay, parathyroid hormone
Product Code
CEW
Regulation Number
862.1545
Device Class
2
Premarket Reviews
Manufacturer
Decision
BECKMAN COULTER INC
SUBSTANTIALLY EQUIVALENT
1
DIASORIN INC.
SUBSTANTIALLY EQUIVALENT
1
DIASORIN, INC.
SUBSTANTIALLY EQUIVALENT
1
FUJIREBIO DIAGNOSTICS, INC.
SUBSTANTIALLY EQUIVALENT
1
IMMUNODIAGNOSTIC SYSTEMS LTD
SUBSTANTIALLY EQUIVALENT
1
IMMUNODIAGNOSTIC SYSTEMS LTD.
SUBSTANTIALLY EQUIVALENT
1
ORTHO CLINICAL DIAGNOSTICS
SUBSTANTIALLY EQUIVALENT
1
ORTHO-CLINICAL DIAGNOSTICS
SUBSTANTIALLY EQUIVALENT
1
ROCHE DIAGNOSTICS
SUBSTANTIALLY EQUIVALENT
1
SIEMENS HEALTHCARE DIAGNOSTICS
SUBSTANTIALLY EQUIVALENT
1
SIEMENS HEALTHCARE DIAGNOSTICS INC.
SUBSTANTIALLY EQUIVALENT
2
MDR Year
MDR Reports
MDR Events
2014
167
167
2015
56
56
2016
98
98
2017
83
83
2018
65
65
2019
77
77
2020
50
50
2021
57
57
2022
188
188
2023
82
97
2024
45
45
Device Problems
MDRs with this Device Problem
Events in those MDRs
High Test Results
453
453
Low Test Results
315
315
False Positive Result
82
82
Adverse Event Without Identified Device or Use Problem
69
69
Nonstandard Device
53
53
Incorrect, Inadequate or Imprecise Result or Readings
26
26
Device Ingredient or Reagent Problem
26
26
Incorrect Or Inadequate Test Results
22
22
No Apparent Adverse Event
20
20
Non Reproducible Results
17
17
Incorrect Measurement
16
16
Low Readings
7
7
Output Problem
5
5
Erratic Results
5
20
High Readings
2
2
Mechanical Problem
2
2
False Reading From Device Non-Compliance
2
2
Appropriate Term/Code Not Available
2
2
Unexpected Therapeutic Results
2
2
Inadequate Instructions for Healthcare Professional
1
1
Loose or Intermittent Connection
1
1
Device Displays Incorrect Message
1
1
Mechanical Jam
1
1
False Negative Result
1
1
Communication or Transmission Problem
1
1
Device Handling Problem
1
1
Calibration Problem
1
1
Device Operates Differently Than Expected
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
366
381
No Known Impact Or Consequence To Patient
355
355
No Consequences Or Impact To Patient
228
228
Test Result
9
9
No Code Available
5
5
Insufficient Information
5
5
No Patient Involvement
3
3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
2
2
Solid Tumour
2
2
Hormonal Imbalance
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Beckman Coulter Inc.
II
Dec-09-2010
2
Beckman Coulter Inc.
II
Oct-20-2010
3
Diagnostic Hybrids, Inc.
III
Apr-25-2018
4
Diasorin Inc.
II
Apr-01-2021
5
Future Diagnostics Solutions B.V.
II
Jan-25-2023
6
ORTHO-CLINICAL DIAGNOSTICS
II
Dec-23-2016
7
Ortho-Clinical Diagnostics, Inc.
II
Jan-04-2023
8
Siemens Healthcare Diagnostics, Inc
III
Nov-06-2013
9
Siemens Healthcare Diagnostics, Inc
II
Jun-06-2013
10
Siemens Healthcare Diagnostics, Inc
II
Mar-07-2012
11
Siemens Healthcare Diagnostics, Inc.
II
Jan-09-2017
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