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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 myoglobin, antigen, antiserum, control
Regulation Description Myoglobin immunological test system.
Product CodeDDR
Regulation Number 866.5680
Device Class 2

MDR Year MDR Reports MDR Events
2016 3 3
2017 5 5
2018 3 3
2019 6 7
2020 2 2
2021 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Low Test Results 13 13
High Test Results 3 3
Incorrect, Inadequate or Imprecise Resultor Readings 3 4
Incorrect Or Inadequate Test Results 1 1
Nonstandard Device 1 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 12 13
No Consequences Or Impact To Patient 6 6
No Clinical Signs, Symptoms or Conditions 2 2

Recalls
Manufacturer Recall Class Date Posted
1 Roche Diagnostics Operations, Inc. II Aug-30-2019
2 Siemens Healthcare Diagnostics Inc II Jan-07-2016
3 Siemens Healthcare Diagnostics, Inc II Sep-28-2016
4 Tosoh Bioscience Inc II Jun-05-2018
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