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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device culture media, antimicrobial susceptibility test, excluding mueller hinton agar
Regulation Description Culture medium for antimicrobial susceptibility tests.
Product CodeJSO
Regulation Number 866.1700
Device Class 2

MDR Year MDR Reports MDR Events
2020 7 7
2021 27 27
2022 8 8
2023 12 12
2024 4 4
2025 120 120

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect, Inadequate or Imprecise Result or Readings 153 153
False Negative Result 5 5
Device Markings/Labelling Problem 4 4
Defective Device 3 3
Contamination of Device Ingredient or Reagent 3 3
False Positive Result 3 3
Device Ingredient or Reagent Problem 2 2
Contamination 2 2
Output Problem 1 1
Incorrect Measurement 1 1
Device Contamination with Chemical or Other Material 1 1
Nonstandard Device 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 167 167
No Known Impact Or Consequence To Patient 8 8
No Consequences Or Impact To Patient 3 3
Drug Resistant Bacterial Infection 1 1
Insufficient Information 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Biomerieux Inc II Jan-04-2023
2 Hardy Diagnostics II Jun-27-2025
3 Hardy Diagnostics II Jan-25-2021
4 Hardy Diagnostics II Jun-09-2020
5 Remel Inc II May-12-2021
6 Remel Inc II Apr-13-2021
7 Remel, Inc II Jun-29-2023
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