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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
2018 38 38
2019 36 39
2020 135 135
2021 43 43
2022 61 61
2023 42 42

Device Problems MDRs with this Device Problem Events in those MDRs
High Test Results 183 186
Low Test Results 82 82
Incorrect, Inadequate or Imprecise Result or Readings 59 59
Non Reproducible Results 36 36
No Apparent Adverse Event 14 14
Incorrect Measurement 11 11
Device Damaged Prior to Use 2 2
Incorrect Or Inadequate Test Results 2 2
Calibration Problem 2 2
Adverse Event Without Identified Device or Use Problem 2 2
Device Markings/Labelling Problem 1 1
Material Integrity Problem 1 1
Low Readings 1 1
Unable to Obtain Readings 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 129 132
No Clinical Signs, Symptoms or Conditions 106 106
No Code Available 39 39
No Consequences Or Impact To Patient 39 39
Insufficient Information 35 35
Overdose 4 4
Therapeutic Response, Increased 2 2
No Patient Involvement 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Misdiagnosis 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Abbott Ireland Diagnostics Division II May-16-2019
2 Abbott Ireland Diagnostics Division II Dec-22-2018
3 Biomerieux Inc II Jan-04-2023
4 Siemens Healthcare Diagnostics, Inc II Feb-04-2018
5 Siemens Healthcare Diagnostics, Inc. II Apr-29-2022
6 Siemens Healthcare Diagnostics, Inc. II Feb-24-2020
7 Siemens Healthcare Diagnostics, Inc. II Jul-13-2018
8 Tosoh Bioscience Inc II Jun-05-2018
9 bioMerieux, Inc. II Dec-28-2021
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