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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device stains, microbiologic
Regulation Description Dye and chemical solution stains.
Product CodeJTS
Regulation Number 864.1850
Device Class 1

MDR Year MDR Reports MDR Events
2021 4 4
2023 5 5
2024 21 21
2025 102 102
2026 13 13

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect, Inadequate or Imprecise Result or Readings 85 85
Device Markings/Labelling Problem 30 30
Contamination 21 21
Expiration Date Error 5 5
Leak/Splash 1 1
Off-Label Use 1 1
Device Contamination with Chemical or Other Material 1 1
Missing Information 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 143 143
Chemical Exposure 1 1
Abrasion 1 1
Discomfort 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Becton Dickinson & Co. II Mar-06-2025
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