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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device bromcresol purple dye-binding, albumin
Product CodeCJW
Regulation Number 862.1035
Device Class 2


Premarket Reviews
ManufacturerDecision
ABBOTT IRELAND DIAGNOSTICS DIVISION
  SUBSTANTIALLY EQUIVALENT 1
SENTINEL CH. SPA
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 3 4
2021 5 5
2023 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Low Test Results 7 8
Non Reproducible Results 2 2
Output Problem 1 1
Incorrect, Inadequate or Imprecise Result or Readings 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 8 8
No Consequences Or Impact To Patient 2 2
No Known Impact Or Consequence To Patient 1 2

Recalls
Manufacturer Recall Class Date Posted
1 Roche Diagnostics Corporation II Apr-18-2019
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