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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
2024 31 31

Device Problems MDRs with this Device Problem Events in those MDRs
Product Quality Problem 28 28
Incorrect, Inadequate or Imprecise Result or Readings 24 25
Failure to Calibrate 16 16
Low Test Results 12 12
High Test Results 5 5
False Negative Result 2 2
Non Reproducible Results 2 2
Nonstandard Device 1 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 41 41
No Known Impact Or Consequence To Patient 5 6
No Consequences Or Impact To Patient 2 2

Recalls
Manufacturer Recall Class Date Posted
1 Abbott Laboratories II Apr-04-2024
2 Roche Diagnostics Operations, Inc. II Aug-30-2019
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