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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device radioimmunoassay, progesterone
Product CodeJLS
Regulation Number 862.1620
Device Class 1

MDR Year MDR Reports MDR Events
2019 7 7
2020 4 4
2021 41 41
2022 17 17
2023 18 18
2024 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
High Test Results 47 47
Unable to Obtain Readings 28 28
Low Test Results 6 6
No Apparent Adverse Event 6 6
Incorrect Measurement 1 1
Non Reproducible Results 1 1
Leak/Splash 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 73 73
No Known Impact Or Consequence To Patient 8 8
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 5 5
Insufficient Information 3 3
No Code Available 2 2

Recalls
Manufacturer Recall Class Date Posted
1 Biomerieux Inc II Jan-04-2023
2 DRG Instruments GmbH II Aug-28-2019
3 Siemens Healthcare Diagnostics, Inc. II Aug-17-2019
4 bioMerieux, Inc. II Dec-28-2021
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