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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
Product CodeJHX
Regulation Number 862.1215
Device Class 2


Premarket Reviews
ManufacturerDecision
ORTHO CLINICAL DIAGNOSTICS
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2018 16 16
2019 7 7
2020 3 3
2021 10 10
2022 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
High Test Results 13 13
Low Test Results 9 9
High Readings 5 5
Incorrect Or Inadequate Test Results 5 5
Incorrect, Inadequate or Imprecise Result or Readings 4 4
False Positive Result 2 2
Adverse Event Without Identified Device or Use Problem 2 2
No Apparent Adverse Event 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 15 15
No Clinical Signs, Symptoms or Conditions 13 13
No Known Impact Or Consequence To Patient 10 10

Recalls
Manufacturer Recall Class Date Posted
1 Polymedco, Inc.,/Polymedco Cancer Diagnostic Products, Llc II Sep-17-2018
2 Tosoh Bioscience Inc II Jun-05-2018
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