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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device radioimmunoassay, estradiol
Regulation Description Estradiol test system.
Product CodeCHP
Regulation Number 862.1260
Device Class 1

MDR Year MDR Reports MDR Events
2021 43 43
2022 61 61
2023 60 62
2024 65 65
2025 86 86
2026 34 34

Device Problems MDRs with this Device Problem Events in those MDRs
High Test Results 233 234
Non Reproducible Results 100 101
Low Test Results 86 87
Incorrect, Inadequate or Imprecise Result or Readings 37 39
Incorrect Measurement 36 36
Output Problem 4 4
Low Readings 4 4
Insufficient Information 3 3
High Readings 3 3
Mechanical Problem 2 2
Material Integrity Problem 2 3
Calibration Problem 2 2
Failure to Calibrate 2 2
Chemical Problem 1 1
Device Damaged Prior to Use 1 1
Device Markings/Labelling Problem 1 1
Defective Device 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Unable to Obtain Readings 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 304 306
Insufficient Information 37 37
No Known Impact Or Consequence To Patient 4 4
No Consequences Or Impact To Patient 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Unspecified Reproductive System or Breast Problem 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Biomerieux Inc II Jan-04-2023
2 Siemens Healthcare Diagnostics, Inc. II Apr-29-2022
3 bioMerieux, Inc. II Dec-28-2021
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