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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 3
HYCOR BIOMEDICAL
  SUBSTANTIALLY EQUIVALENT 4
PHADIA AB
  SUBSTANTIALLY EQUIVALENT 15
PHADIA US INC.
  SUBSTANTIALLY EQUIVALENT 4
SIEMENS HEALTHCARE DIAGNOSTICS
  SUBSTANTIALLY EQUIVALENT 6
SIEMENS HEALTHCARE DIAGNOSTICS INC.
  SUBSTANTIALLY EQUIVALENT 3
SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS
  SUBSTANTIALLY EQUIVALENT 2
THERMO FISHER SCIENTIFIC
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2015 1 1
2017 11 11
2018 6 6
2019 4 4
2021 7 7
2022 1 1
2023 6 6
2024 5 5

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 13 13
False Negative Result 11 11
Low Test Results 11 11
Shipping Damage or Problem 3 3
Device Handling Problem 3 3
Manufacturing, Packaging or Shipping Problem 1 1
Device Markings/Labelling Problem 1 1
High Test Results 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 21 21
No Clinical Signs, Symptoms or Conditions 19 19
Nausea 1 1
Dizziness 1 1
Discomfort 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Hitachi Chemical Diagnostics Inc III Feb-07-2013
2 Hycor Biomedical LLC II Oct-29-2019
3 Phadia Ab II Aug-26-2019
4 Phadia Ab II Mar-30-2018
5 Phadia US Inc II Apr-05-2018
6 Phadia US Inc II Jan-18-2018
7 Phadia US Inc II Jan-12-2015
8 Siemens Healthcare Diagnostics, Inc. II Dec-15-2022
9 Siemens Healthcare Diagnostics, Inc. II May-04-2018
10 Siemens Healthcare Diagnostics, Inc. II Jun-25-2015
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