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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
NOVA BIOMEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
QURASENSE
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2021 7 8
2022 8 8
2023 27 28
2024 39 39
2025 22 22
2026 54 54

Device Problems MDRs with this Device Problem Events in those MDRs
High Test Results 79 80
Therapeutic or Diagnostic Output Failure 25 25
Computer Software Problem 25 25
Non Reproducible Results 20 21
Incorrect, Inadequate or Imprecise Result or Readings 18 18
Low Test Results 11 11
No Apparent Adverse Event 5 5
Output Problem 3 3
Insufficient Information 3 4
Use of Device Problem 3 3
Incorrect Measurement 3 3
Chemical Problem 2 2
Device Markings/Labelling Problem 2 2
Smoking 2 2
Calibration Problem 2 2
Appropriate Term/Code Not Available 2 2
Leak/Splash 1 1
Mechanical Problem 1 1
Material Integrity Problem 1 1
Patient Data Problem 1 1
High Readings 1 1
Unable to Obtain Readings 1 2
Use of Incorrect Control/Treatment Settings 1 1
Data Problem 1 1
Product Quality Problem 1 1
Low Readings 1 1
Failure to Calibrate 1 1
Unexpected Therapeutic Results 1 1
Failure to Analyze Signal 1 1
False Positive Result 1 1
Device Displays Incorrect Message 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 128 130
Needle Stick/Puncture 25 25
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Exposure to Body Fluids 1 1
Insufficient Information 1 1
Hyperglycemia 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Abbott Diagnostics Technologies AS II Aug-27-2024
2 GET TESTED INTERNATIONAL AB II Dec-01-2025
3 Mckesson Medical-Surgical Inc. Corporate Office II May-27-2025
4 Polymer Technology Systems, Inc. dba PTS Diagnostics, Inc. II Oct-24-2024
5 Siemens Healthcare Diagnostics, Inc. II Mar-19-2024
6 Siemens Healthcare Diagnostics, Inc. II Apr-14-2022
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