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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 igg, antigen, antiserum, control
Regulation Description Immunoglobulins A, G, M, D, and E immunological test system.
Product CodeDEW
Regulation Number 866.5510
Device Class 2

MDR Year MDR Reports MDR Events
2016 4 4
2017 6 6
2018 1 1
2019 9 9
2020 19 19
2021 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect, Inadequate or Imprecise Resultor Readings 30 30
Incorrect Or Inadequate Test Results 3 3
Low Test Results 3 3
Adverse Event Without Identified Device or Use Problem 1 1
Occlusion Within Device 1 1
Output Problem 1 1
Pumping Problem 1 1
Appropriate Term/Code Not Available 1 1
Complete Blockage 1 1
False Negative Result 1 1
False Positive Result 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 31 31
No Consequences Or Impact To Patient 6 6
No Clinical Signs, Symptoms or Conditions 2 2
Misdiagnosis 1 1
No Patient Involvement 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Abbott Laboratories, Inc II Jul-19-2019
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