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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device bromcresol green dye-binding, albumin
Product CodeCIX
Regulation Number 862.1035
Device Class 2


Premarket Reviews
ManufacturerDecision
ABBOTT IRELAND DIAGNOSTICS DIVISION
  SUBSTANTIALLY EQUIVALENT 1
MEDICON HELLAS, S.A
  SUBSTANTIALLY EQUIVALENT 1
ORTHO-CLINICAL DIAGNOSTICS, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 1 1
2021 3 3
2022 1 1
2023 5 5
2024 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Low Test Results 8 8
Incorrect, Inadequate or Imprecise Result or Readings 4 4
Non Reproducible Results 3 3
Unexpected Therapeutic Results 1 1
High Test Results 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 10 10
No Consequences Or Impact To Patient 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Roche Diagnostics Operations, Inc. III Oct-13-2020
2 Roche Diagnostics Operations, Inc. III Oct-16-2019
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