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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device container, specimen mailer and storage, non-sterile
Product CodeNNK
Regulation Number 864.3250
Device Class 1

MDR Year MDR Reports MDR Events
2018 1 1
2019 2 2
2020 1 1
2021 4 4
2022 1 1
2023 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Device Contamination with Chemical or Other Material 1 1
False Negative Result 1 1
Device Markings/Labelling Problem 1 1
Incorrect Or Inadequate Test Results 1 1
Incorrect, Inadequate or Imprecise Result or Readings 1 1
Product Quality Problem 1 1
Improper or Incorrect Procedure or Method 1 1
Patient-Device Incompatibility 1 1
Contamination /Decontamination Problem 1 1
Fail-Safe Problem 1 1
Use of Device Problem 1 1
Appropriate Term/Code Not Available 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 3 3
Insufficient Information 2 2
No Known Impact Or Consequence To Patient 2 2
No Information 1 1
Urticaria 1 1
No Patient Involvement 1 1

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