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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 colorimetric method, cpk or isoenzymes
Product CodeJHY
Regulation Number 862.1215
Device Class 2

MDR Year MDR Reports MDR Events
2017 11 11
2018 5 5
2019 2 2
2020 2 2
2022 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
High Test Results 18 18
Low Test Results 2 2
Incorrect, Inadequate or Imprecise Result or Readings 2 2
Incorrect Or Inadequate Test Results 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 15 15
No Consequences Or Impact To Patient 5 5
No Clinical Signs, Symptoms or Conditions 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Siemens Healthcare Diagnostics, Inc. II May-04-2018
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