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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 fluorometric method, cpk or isoenzymes
Regulation Description Creatine phosphokinase/creatine kinase or isoenzymes test system.
Product CodeJHX
Regulation Number 862.1215
Device Class 2


Premarket Reviews
ManufacturerDecision
RADIOMETER MEDICAL APS
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2016 10 10
2017 3 3
2018 16 16
2019 7 7
2020 3 3
2021 4 4

Device Problems MDRs with this Device Problem Events in those MDRs
High Test Results 17 17
Incorrect, Inadequate or Imprecise Resultor Readings 7 7
Incorrect Or Inadequate Test Results 5 5
Low Test Results 5 5
High Readings 5 5
Adverse Event Without Identified Device or Use Problem 2 2
False Positive Result 2 2
No Apparent Adverse Event 1 1
Use of Device Problem 1 1
Computer Software Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 23 23
No Known Impact Or Consequence To Patient 15 15
No Clinical Signs, Symptoms or Conditions 5 5

Recalls
Manufacturer Recall Class Date Posted
1 Polymedco, Inc.,/Polymedco Cancer Diagnostic Products, Llc II Sep-17-2018
2 Siemens Healthcare Diagnostics Inc II Aug-11-2016
3 Siemens Healthcare Diagnostics Inc II Jan-07-2016
4 Tosoh Bioscience Inc II Jun-05-2018
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