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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device gram-positive bacteria and their resistance markers
Definition A qualitive multiplexed in vitro diagnostic device to detect and identify Gram positive bacteria and resistant markers in positive blood cultures.
Product CodePAM
Regulation Number 866.3365
Device Class 2

MDR Year MDR Reports MDR Events
2020 2 2
2021 2 2
2022 1 1
2023 106 106
2024 285 285

Device Problems MDRs with this Device Problem Events in those MDRs
False Positive Result 376 376
False Negative Result 19 19
Volume Accuracy Problem 1 1
Therapeutic or Diagnostic Output Failure 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 387 387
Insufficient Information 6 6
Death 1 1
Fever 1 1
Unspecified Infection 1 1
Phlebitis 1 1
Renal Failure 1 1
Sepsis 1 1
Respiratory Failure 1 1
Heart Failure/Congestive Heart Failure 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Luminex Corporation II Dec-06-2023
2 Luminex Corporation II Nov-20-2020
3 Luminex Corporation II Aug-10-2020
4 Luminex Corporation III Feb-11-2019
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