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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device myoglobin, antigen, antiserum, control
Product CodeDDR
Regulation Number 866.5680
Device Class 2


Premarket Reviews
ManufacturerDecision
BECKMAN COULTER, INC
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 6 7
2020 2 2
2021 1 1
2022 1 1
2023 7 7

Device Problems MDRs with this Device Problem Events in those MDRs
Low Test Results 10 10
High Test Results 4 4
Incorrect, Inadequate or Imprecise Result or Readings 2 3
Nonstandard Device 1 2
Non Reproducible Results 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 10 10
No Known Impact Or Consequence To Patient 5 6
No Consequences Or Impact To Patient 2 2

Recalls
Manufacturer Recall Class Date Posted
1 Roche Diagnostics Operations, Inc. II Aug-30-2019
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