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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device enzyme immunoassay, gentamicin
Product CodeLCD
Regulation Number 862.3450
Device Class 2

MDR Year MDR Reports MDR Events
2018 2 2
2019 1 1
2020 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Leak/Splash 1 1
Incorrect, Inadequate or Imprecise Result or Readings 1 1
Smoking 1 1
High Test Results 1 1
Device Operates Differently Than Expected 1 1
Noise, Audible 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Skin Irritation 1 1
Renal Failure 1 1
No Known Impact Or Consequence To Patient 1 1
No Patient Involvement 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Abbott Gmbh & Co. KG II May-12-2020
2 Siemens Healthcare Diagnostics, Inc. II Jun-13-2018
3 bioMerieux, Inc. II Sep-15-2018
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