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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device culture media, non-selective and differential
Regulation Description Differential culture medium.
Product CodeJSH
Regulation Number 866.2320
Device Class 1

MDR Year MDR Reports MDR Events
2021 42 42
2022 10 10
2023 8 8
2024 11 11
2025 20 20
2026 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect, Inadequate or Imprecise Result or Readings 55 55
Contamination 26 26
Contamination of Device Ingredient or Reagent 3 3
Device Contaminated During Manufacture or Shipping 2 2
Device Markings/Labelling Problem 2 2
False Positive Result 2 2
Unclear Information 1 1
Microbial Contamination of Device 1 1
Missing Information 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 93 93
No Consequences Or Impact To Patient 3 3
No Patient Involvement 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Remel, Inc II Jul-31-2025
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