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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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New Search show TPLC since Back to Search Results
Device acid, lactic, enzymatic method
Product CodeKHP
Regulation Number 862.1450
Device Class 1

MDR Year MDR Reports MDR Events
2019 10 10
2020 6 6
2021 3 3
2022 7 7
2023 3 3
2024 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect, Inadequate or Imprecise Result or Readings 15 15
High Test Results 8 8
Low Test Results 6 6
Non Reproducible Results 3 3
Erratic Results 1 1
High Readings 1 1
Low Readings 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 14 14
No Known Impact Or Consequence To Patient 7 7
No Information 3 3
Pneumonia 2 2
Renal Failure 2 2
No Consequences Or Impact To Patient 1 1
Injury 1 1
Diabetic Ketoacidosis 1 1
Abdominal Pain 1 1
Adult Respiratory Distress Syndrome 1 1
Fever 1 1
High Blood Pressure/ Hypertension 1 1
Intraocular Pressure Increased 1 1
No Code Available 1 1
Gastroesophageal Burn 1 1
Insufficient Information 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Abbott Point Of Care Inc. II Feb-18-2020
2 Roche Diagnostics Corporation II Apr-13-2019
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