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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Super Search Devices@FDA
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New Search show TPLC since Back to Search Results
Device hemoglobin a1c test system
Definition Quantitative determination of Hemoglobin A1c to aid in the diagnosis of diabetes.
Product CodePDJ
Regulation Number 862.1373
Device Class 2


Premarket Reviews
ManufacturerDecision
BECKMAN COULTER IRELAND INC.
  SUBSTANTIALLY EQUIVALENT 1
ROCHE DIAGNOSTICS OPERATIONS (RDO)
  SUBSTANTIALLY EQUIVALENT 1
SHIJIAZHUANG HIPRO BIOTECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SIEMENS HEALTHCARE DIAGNOSTICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
TOSOH BIOSCIENCE, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 5 5
2021 6 6
2022 19 19
2023 16 16
2024 27 27

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect, Inadequate or Imprecise Result or Readings 32 32
High Test Results 11 11
Low Test Results 5 5
Smoking 3 3
Patient Data Problem 3 3
Noise, Audible 3 3
Material Split, Cut or Torn 2 2
Display Difficult to Read 2 2
Leak/Splash 1 1
Device Ingredient or Reagent Problem 1 1
Fumes or Vapors 1 1
Image Display Error/Artifact 1 1
Insufficient Information 1 1
Defective Component 1 1
Device Emits Odor 1 1
No Apparent Adverse Event 1 1
Device Contamination with Chemical or Other Material 1 1
Low Readings 1 1
Improper or Incorrect Procedure or Method 1 1
Display or Visual Feedback Problem 1 1
No Device Output 1 1
Mechanical Problem 1 1
Device Contamination with Body Fluid 1 1
No Audible Alarm 1 1
High Readings 1 1
Infusion or Flow Problem 1 1
Power Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 64 64
Hyperglycemia 4 4
Insufficient Information 2 2
No Consequences Or Impact To Patient 2 2
Misdiagnosis 1 1
Chest Pain 1 1
Myocardial Infarction 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Abbott Diagnostics Technologies AS II May-29-2020
2 Abbott Laboratories II Jul-22-2022
3 Ortho-Clinical Diagnostics, Inc. II May-24-2023
4 Siemens Healthcare Diagnostics, Inc. II Apr-14-2022
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