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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
2015 59 59
2016 44 67
2017 42 42
2018 3 3
2019 4 4
2020 7 7
2021 10 10
2022 4 4
2023 19 19
2024 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect, Inadequate or Imprecise Result or Readings 123 146
Incorrect Or Inadequate Test Results 48 48
False Positive Result 6 6
Appropriate Term/Code Not Available 4 4
Device Markings/Labelling Problem 4 4
Unable to Obtain Readings 4 4
Leak/Splash 3 3
Contamination 1 1
Incorrect Measurement 1 1
Low Readings 1 1
Tear, Rip or Hole in Device Packaging 1 1
Device Operates Differently Than Expected 1 1
False Negative Result 1 1
Fluid/Blood Leak 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 90 106
No Consequences Or Impact To Patient 37 60
No Clinical Signs, Symptoms or Conditions 34 34
No Patient Involvement 34 39
No Code Available 3 3
Misdiagnosis 1 1
No Information 1 1
Skin Discoloration 1 1
Laceration(s) 1 1
Meningitis 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Becton Dickinson & Co. II May-29-2013
2 Becton Dickinson & Co. III Mar-04-2010
3 BioMerieux SA II Jun-12-2018
4 Biomerieux Inc II Jan-04-2023
5 Gibson Bioscience II Sep-10-2021
6 MEDLINE INDUSTRIES, LP - Northfield II Feb-02-2022
7 Remel Inc II Dec-18-2013
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