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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
2017 39 39
2018 38 38
2019 36 39
2020 135 135
2021 43 43
2022 55 55

Device Problems MDRs with this Device Problem Events in those MDRs
High Test Results 156 159
Low Test Results 75 75
Incorrect, Inadequate or Imprecise Result or Readings 56 56
Adverse Event Without Identified Device or Use Problem 23 23
Non Reproducible Results 19 19
No Apparent Adverse Event 14 14
Incorrect Or Inadequate Test Results 12 12
Incorrect Measurement 7 7
Calibration Problem 6 6
Device Markings/Labelling Problem 1 1
Low Readings 1 1
Unable to Obtain Readings 1 1
Device Damaged Prior to Use 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 164 167
No Clinical Signs, Symptoms or Conditions 62 62
No Consequences Or Impact To Patient 43 43
No Code Available 39 39
Insufficient Information 30 30
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 SA II Mar-20-2017
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 Siemens Healthcare Diagnostics, Inc. II May-05-2017
9 Tosoh Bioscience Inc II Jun-05-2018
10 bioMerieux, Inc. II Dec-28-2021
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