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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
FUJIREBIO DIAGNOSTICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
ORTHO CLINICAL DIAGNOSTICS
  SUBSTANTIALLY EQUIVALENT 1
ROCHE DIAGNOSTICS
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 77 77
2020 50 50
2021 57 57
2022 188 188
2023 82 97
2024 31 31

Device Problems MDRs with this Device Problem Events in those MDRs
Low Test Results 263 263
High Test Results 241 241
No Apparent Adverse Event 17 17
Non Reproducible Results 16 16
Incorrect Measurement 12 12
Incorrect, Inadequate or Imprecise Result or Readings 7 7
Low Readings 6 6
Erratic Results 5 20
Output Problem 2 2
Device Ingredient or Reagent Problem 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Unexpected Therapeutic Results 1 1
Mechanical Problem 1 1
False Negative Result 1 1
High Readings 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 352 367
No Known Impact Or Consequence To Patient 87 87
No Consequences Or Impact To Patient 37 37
Insufficient Information 5 5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Solid Tumour 2 2
Test Result 2 2
Hormonal Imbalance 1 1
No Patient Involvement 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Diasorin Inc. II Apr-01-2021
2 Future Diagnostics Solutions B.V. II Jan-25-2023
3 Ortho-Clinical Diagnostics, Inc. II Jan-04-2023
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