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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 20 20

Device Problems MDRs with this Device Problem Events in those MDRs
Product Quality Problem 20 20
Incorrect, Inadequate or Imprecise Result or Readings 20 21
Failure to Calibrate 13 13
Low Test Results 11 11
High Test Results 5 5
Non Reproducible Results 1 1
Nonstandard Device 1 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 30 30
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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