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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
2014 12 12
2015 18 18
2016 29 29
2017 39 39
2018 38 38
2019 36 39
2020 135 135
2021 43 43
2022 61 61
2023 60 60
2024 21 21

Device Problems MDRs with this Device Problem Events in those MDRs
High Test Results 222 225
Low Test Results 121 121
Incorrect, Inadequate or Imprecise Result or Readings 78 78
Non Reproducible Results 50 50
Adverse Event Without Identified Device or Use Problem 27 27
Incorrect Or Inadequate Test Results 18 18
No Apparent Adverse Event 14 14
Incorrect Measurement 12 12
Calibration Problem 6 6
False Reading From Device Non-Compliance 3 3
Low Readings 2 2
Device Damaged Prior to Use 2 2
Appropriate Term/Code Not Available 2 2
Insufficient Information 1 1
Device Markings/Labelling Problem 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Material Integrity Problem 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 195 198
No Clinical Signs, Symptoms or Conditions 145 145
No Consequences Or Impact To Patient 62 62
No Code Available 41 41
Insufficient Information 35 35
Misdiagnosis 7 7
Overdose 4 4
Therapeutic Response, Increased 2 2
No Patient Involvement 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Death 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 Abbott Laboratories II May-31-2016
4 Beckman Coulter Inc. II Nov-23-2010
5 BioMerieux SA II Mar-20-2017
6 Biomerieux Inc II Jan-04-2023
7 Diasorin Inc. II Nov-21-2016
8 ORTHO-CLINICAL DIAGNOSTICS II Aug-05-2016
9 Roche Diagnostics Operations, Inc. II Mar-31-2016
10 Siemens Healthcare Diagnostics, Inc II Feb-04-2018
11 Siemens Healthcare Diagnostics, Inc II Mar-24-2016
12 Siemens Healthcare Diagnostics, Inc. II Apr-29-2022
13 Siemens Healthcare Diagnostics, Inc. II Feb-24-2020
14 Siemens Healthcare Diagnostics, Inc. II Jul-13-2018
15 Siemens Healthcare Diagnostics, Inc. II May-05-2017
16 Tosoh Bioscience Inc II Jun-05-2018
17 bioMerieux, Inc. II Dec-28-2021
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