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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 55 55

Device Problems MDRs with this Device Problem Events in those MDRs
High Test Results 216 219
Low Test Results 93 93
Non Reproducible Results 63 63
Incorrect, Inadequate or Imprecise Result or Readings 60 60
Incorrect Measurement 18 18
Low Readings 4 4
No Apparent Adverse Event 4 4
High Readings 3 3
Calibration Problem 2 2
Failure to Calibrate 2 2
Mechanical Problem 1 1
Device Damaged Prior to Use 1 1
Device Markings/Labelling Problem 1 1
Insufficient Information 1 1
Defective Device 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Material Integrity Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 179 179
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
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Therapeutic Response, Increased 2 2
Misdiagnosis 1 1
No Patient Involvement 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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