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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device culture media, selective and differential
Regulation Description Selective culture medium.
Product CodeJSI
Regulation Number 866.2360
Device Class 1

MDR Year MDR Reports MDR Events
2021 83 83
2022 88 88
2023 36 36
2024 22 22
2025 42 42

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect, Inadequate or Imprecise Result or Readings 122 122
Contamination 86 86
Contamination of Device Ingredient or Reagent 24 24
False Negative Result 16 16
Device Markings/Labelling Problem 9 9
False Positive Result 5 5
Microbial Contamination of Device 4 4
Device Contamination with Chemical or Other Material 4 4
Missing Information 3 3

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 270 270
No Patient Involvement 3 3
No Consequences Or Impact To Patient 3 3
Insufficient Information 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Biomerieux Inc II Jan-04-2023
2 Mckesson Medical-Surgical Inc. Corporate Office II May-27-2025
3 Remel Inc II Jan-14-2021
4 Remel, Inc II Jul-31-2025
5 Remel, Inc II Feb-20-2025
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