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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device system, test, radioallergosorbent (rast) immunological
Product CodeDHB
Regulation Number 866.5750
Device Class 2


Premarket Reviews
ManufacturerDecision
HITACHI CHEMICAL DIAGNOSTICS, INC.
  SUBSTANTIALLY EQUIVALENT 2
HYCOR BIOMEDICAL
  SUBSTANTIALLY EQUIVALENT 3
PHADIA AB
  SUBSTANTIALLY EQUIVALENT 3

MDR Year MDR Reports MDR Events
2019 4 4
2021 7 7
2022 1 1
2023 6 6
2024 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
False Negative Result 11 11
Low Test Results 8 8
Device Handling Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 16 16
No Known Impact Or Consequence To Patient 4 4

Recalls
Manufacturer Recall Class Date Posted
1 Hycor Biomedical LLC II Oct-29-2019
2 Phadia Ab II Aug-26-2019
3 Siemens Healthcare Diagnostics, Inc. II Dec-15-2022
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