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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
Regulation Description Myoglobin immunological test system.
Product CodeDDR
Regulation Number 866.5680
Device Class 2


Premarket Reviews
ManufacturerDecision
BECKMAN COULTER, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2021 1 1
2022 1 1
2023 7 7
2024 31 31
2025 5 5
2026 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Product Quality Problem 28 28
Incorrect, Inadequate or Imprecise Result or Readings 24 24
Failure to Calibrate 16 16
Low Test Results 10 10
High Test Results 5 5
Non Reproducible Results 3 3
False Negative Result 2 2
Device Difficult to Setup or Prepare 1 1
Incorrect Measurement 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 47 47

Recalls
Manufacturer Recall Class Date Posted
1 Abbott Laboratories II Apr-04-2024
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