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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device stains, microbiologic
Product CodeJTS
Regulation Number 864.1850
Device Class 1

MDR Year MDR Reports MDR Events
2020 106 106
2021 4 4
2023 5 5
2024 4 4

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect, Inadequate or Imprecise Result or Readings 41 41
Device Contamination with Chemical or Other Material 35 35
Signal Artifact/Noise 21 21
False Positive Result 19 19
Precipitate in Device or Device Ingredient 13 13
Image Display Error/Artifact 6 6
Contamination /Decontamination Problem 5 5
Clumping in Device or Device Ingredient 2 2
Defective Device 2 2
Off-Label Use 1 1
Device Markings/Labelling Problem 1 1
Missing Information 1 1
Leak/Splash 1 1
Therapeutic or Diagnostic Output Failure 1 1
Improper or Incorrect Procedure or Method 1 1
Contamination 1 1
Moisture Damage 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 78 78
No Consequences Or Impact To Patient 12 12
No Clinical Signs, Symptoms or Conditions 11 11
Test Result 9 9
No Code Available 5 5
Therapeutic Effects, Unexpected 4 4
No Patient Involvement 2 2
Bacterial Infection 2 2
Fungus 1 1
Fungal Infection 1 1
Abrasion 1 1
Chemical Exposure 1 1
Discomfort 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Becton Dickinson & Co. II May-19-2020
2 Becton Dickinson & Co. II Jul-18-2012
3 BioMerieux SA II Jun-12-2018
4 Remel Inc II Nov-25-2014
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