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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Super Search Devices@FDA
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Device system, test, radioallergosorbent (rast) immunological
Regulation Description Radioallergosorbent (RAST) immunological test system.
Product CodeDHB
Regulation Number 866.5750
Device Class 2


Premarket Reviews
ManufacturerDecision
HITACHI CHEMICAL DIAGNOSTICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
HITACHI MEDICAL CORP.
  SUBSTANTIALLY EQUIVALENT 1
HYCOR BIOMEDICAL
  SUBSTANTIALLY EQUIVALENT 3
PHADIA AB
  SUBSTANTIALLY EQUIVALENT 7

MDR Year MDR Reports MDR Events
2015 1 1
2017 11 11
2018 6 6
2019 4 4

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 13 13
Shipping Damage or Problem 3 3
Device Handling Problem 2 2
False Negative Result 2 2
Low Test Results 2 2
Device Markings/Labelling Problem 1 1
Manufacturing, Packaging or Shipping 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
Nausea 1 1
Dizziness 1 1
Discomfort 1 1

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