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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device radioimmunoassay, estradiol
Product CodeCHP
Regulation Number 862.1260
Device Class 1

MDR Year MDR Reports MDR Events
2019 36 39
2020 135 135
2021 43 43
2022 61 61
2023 60 60
2024 22 22

Device Problems MDRs with this Device Problem Events in those MDRs
High Test Results 191 194
Low Test Results 92 92
Incorrect, Inadequate or Imprecise Result or Readings 59 59
Non Reproducible Results 50 50
Incorrect Measurement 13 13
No Apparent Adverse Event 4 4
Low Readings 2 2
Calibration Problem 2 2
Device Markings/Labelling Problem 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Material Integrity Problem 1 1
Device Damaged Prior to Use 1 1
High Readings 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 146 146
No Known Impact Or Consequence To Patient 109 112
Insufficient Information 35 35
No Code Available 34 34
No Consequences Or Impact To Patient 26 26
Overdose 4 4
Therapeutic Response, Increased 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
No Patient Involvement 1 1
Misdiagnosis 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Abbott Ireland Diagnostics Division II May-16-2019
2 Biomerieux Inc II Jan-04-2023
3 Siemens Healthcare Diagnostics, Inc. II Apr-29-2022
4 Siemens Healthcare Diagnostics, Inc. II Feb-24-2020
5 bioMerieux, Inc. II Dec-28-2021
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