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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device assay, glycosylated hemoglobin
Regulation Description Glycosylated hemoglobin assay.
Product CodeLCP
Regulation Number 864.7470
Device Class 2


Premarket Reviews
ManufacturerDecision
ABBOTT DIAGNOSTICS TECHNOLOGIES AS
  SUBSTANTIALLY EQUIVALENT 1
JANA CARE, INC
  SUBSTANTIALLY EQUIVALENT 1
NOVA BIOMEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
QURASENSE
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 13 13
2021 7 8
2022 8 8
2023 34 34
2024 46 46
2025 5 5

Device Problems MDRs with this Device Problem Events in those MDRs
High Test Results 62 62
Non Reproducible Results 21 21
Incorrect, Inadequate or Imprecise Result or Readings 17 17
Low Test Results 12 12
Output Problem 5 5
No Apparent Adverse Event 4 4
Use of Device Problem 3 3
Smoking 2 2
High Readings 2 2
Incorrect Measurement 2 2
Leak/Splash 1 1
Chemical Problem 1 1
Fire 1 1
Mechanical Problem 1 1
Device Markings/Labelling Problem 1 1
Insufficient Information 1 1
Fail-Safe Did Not Operate 1 1
Material Integrity Problem 1 1
Patient Data Problem 1 1
Unable to Obtain Readings 1 2
Data Problem 1 1
Low Readings 1 1
Failure to Calibrate 1 1
Appropriate Term/Code Not Available 1 1
False Positive Result 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 99 100
No Known Impact Or Consequence To Patient 7 7
No Consequences Or Impact To Patient 4 4
Exposure to Body Fluids 1 1
No Patient Involvement 1 1
Hyperglycemia 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Abbott Diagnostics Technologies AS II Aug-27-2024
2 Polymer Technology Systems, Inc. dba PTS Diagnostics, Inc. II Oct-24-2024
3 Siemens Healthcare Diagnostics, Inc. II Mar-19-2024
4 Siemens Healthcare Diagnostics, Inc. II Apr-14-2022
5 Siemens Healthcare Diagnostics, Inc. II Jul-31-2020
6 Siemens Healthcare Diagnostics, Inc. II Jun-05-2020
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