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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
9
9
Device Problems
MDRs with this Device Problem
Events in those MDRs
High Test Results
436
436
Low Test Results
288
288
False Positive Result
82
82
Adverse Event Without Identified Device or Use Problem
69
69
Nonstandard Device
53
53
Device Ingredient or Reagent Problem
26
26
Incorrect, Inadequate or Imprecise Result or Readings
23
23
Incorrect Or Inadequate Test Results
22
22
No Apparent Adverse Event
20
20
Non Reproducible Results
15
15
Incorrect Measurement
15
15
Low Readings
7
7
Erratic Results
5
20
Output Problem
3
3
Appropriate Term/Code Not Available
2
2
High Readings
2
2
Mechanical Problem
2
2
Unexpected Therapeutic Results
2
2
False Reading From Device Non-Compliance
2
2
Inadequate Instructions for Healthcare Professional
1
1
Loose or Intermittent Connection
1
1
False Negative Result
1
1
Device Displays Incorrect Message
1
1
Calibration Problem
1
1
Communication or Transmission Problem
1
1
Device Handling Problem
1
1
Device Operates Differently Than Expected
1
1
Mechanical Jam
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Known Impact Or Consequence To Patient
355
355
No Clinical Signs, Symptoms or Conditions
331
346
No Consequences Or Impact To Patient
228
228
Test Result
9
9
No Code Available
5
5
Insufficient Information
4
4
No Patient Involvement
3
3
Solid Tumour
2
2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
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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