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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 enzymatic method, ammonia
Regulation Description Ammonia test system.
Product CodeJIF
Regulation Number 862.1065
Device Class 1


Premarket Reviews
ManufacturerDecision
ROCHE DIAGNOSTICS OPERATIONS (RDO)
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2015 3 3
2016 4 4
2017 7 7
2018 1 1
2019 1 1
2020 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Low Test Results 7 7
High Test Results 6 6
Incorrect Or Inadequate Test Results 3 3
Visual Prompts will not Clear 2 2
Device Operates Differently Than Expected 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 12 12
No Consequences Or Impact To Patient 3 3
No Patient Involvement 2 2

Recalls
Manufacturer Recall Class Date Posted
1 RANDOX LABORATORIES, LTD. II Sep-14-2020
2 Sekisui Diagnostics P.E.I. Inc. II Jan-23-2017
3 Sentinel CH SpA II Oct-26-2015
4 Siemens Healthcare Diagnostics, Inc. II Oct-11-2018
5 Siemens Healthcare Diagnostics, Inc. II May-04-2018
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