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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device discs, strips and reagents, microorganism differentiation
Product CodeJTO
Regulation Number 866.2660
Device Class 1

MDR Year MDR Reports MDR Events
2019 4 4
2020 7 7
2021 10 10
2022 4 4
2023 19 19
2024 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect, Inadequate or Imprecise Result or Readings 28 28
False Positive Result 6 6
Device Markings/Labelling Problem 4 4
Leak/Splash 3 3
Unable to Obtain Readings 3 3
Contamination 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 33 33
No Patient Involvement 8 8
No Known Impact Or Consequence To Patient 4 4

Recalls
Manufacturer Recall Class Date Posted
1 Biomerieux Inc II Jan-04-2023
2 Gibson Bioscience II Sep-10-2021
3 MEDLINE INDUSTRIES, LP - Northfield II Feb-02-2022
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