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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 non-differential
Regulation Description Multipurpose culture medium.
Product CodeJSG
Regulation Number 866.2300
Device Class 1

MDR Year MDR Reports MDR Events
2021 177 177
2022 198 198
2023 182 183
2024 32 32
2025 228 228
2026 15 15

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect, Inadequate or Imprecise Result or Readings 405 405
Contamination 236 236
Device Markings/Labelling Problem 76 76
Contamination of Device Ingredient or Reagent 56 56
Microbial Contamination of Device 13 13
Device Contamination with Chemical or Other Material 13 13
Missing Information 6 6
Leak/Splash 1 1
Break 1 1
False Negative Result 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Contamination /Decontamination Problem 1 1
Product Quality Problem 1 1
Inaccurate Information 1 1
False Positive Result 1 1
Improper or Incorrect Procedure or Method 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 819 819
No Consequences Or Impact To Patient 10 10
No Patient Involvement 7 7
Insufficient Information 5 6
Needle Stick/Puncture 1 1
Prolapse 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Mckesson Medical-Surgical Inc. Corporate Office II May-27-2025
2 Vectornate USA Inc II Apr-13-2021
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