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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
BECKMAN COULTER, INC.
  SUBSTANTIALLY EQUIVALENT 1
DIAZYME LABORATORIES
  SUBSTANTIALLY EQUIVALENT 1
ROCHE DIAGNOSTICS
  SUBSTANTIALLY EQUIVALENT 1
SIEMENS HEALTHCARE DIAGNOSTICS INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 1 1
2016 3 3
2017 5 5
2018 3 3
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 25 26
Low Test Results 20 20
Failure to Calibrate 16 16
High Test Results 7 7
False Negative Result 2 2
Non Reproducible Results 2 2
Incorrect Or Inadequate Test Results 1 1
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 12 13
No Consequences Or Impact To Patient 6 6
Misdiagnosis 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Abbott Laboratories II Apr-04-2024
2 Abbott Laboratories II Apr-15-2009
3 Beckman Coulter Inc III May-22-2009
4 Roche Diagnostics Operations, Inc. II Aug-30-2019
5 Siemens Healthcare Diagnostics Inc II Jan-07-2016
6 Siemens Healthcare Diagnostics, Inc II Sep-28-2016
7 Tosoh Bioscience Inc II Jun-05-2018
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