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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device radioimmunoassay, parathyroid hormone
Product CodeCEW
Regulation Number 862.1545
Device Class 2


Premarket Reviews
ManufacturerDecision
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
Device Ingredient or Reagent Problem 26 26
Incorrect, Inadequate or Imprecise Result or Readings 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
Erratic Results 5 20
Output Problem 5 5
High Readings 2 2
Appropriate Term/Code Not Available 2 2
Mechanical Problem 2 2
False Reading From Device Non-Compliance 2 2
Unexpected Therapeutic Results 2 2
Inadequate Instructions for Healthcare Professional 1 1
Device Operates Differently Than Expected 1 1
False Negative Result 1 1
Communication or Transmission Problem 1 1
Device Handling Problem 1 1
Calibration Problem 1 1
Device Displays Incorrect Message 1 1
Mechanical Jam 1 1
Loose or Intermittent Connection 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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