Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
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
HYCOR BIOMEDICAL
  SUBSTANTIALLY EQUIVALENT 6
PHADIA AB
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2021 7 7
2022 1 1
2023 6 6
2024 10 10
2025 6 6
2026 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Low Test Results 18 18
False Negative Result 9 9
Insufficient Device Problem Information 1 1
Incorrect Measurement 1 1
Fluid/Blood Leak 1 1
Installation-Related Problem 1 1
Incorrect, Inadequate or Imprecise Result or Readings 1 1
Device Handling Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 30 30
Bruise/Contusion 1 1
Exposure to Body Fluids 1 1
Insufficient Information 1 1
Anaphylactoid / Anaphylaxis 1 1

Recalls
Manufacturer Recall Class Date Posted
1 GET TESTED INTERNATIONAL AB II Dec-01-2025
2 Siemens Healthcare Diagnostics, Inc. II Nov-13-2025
3 Siemens Healthcare Diagnostics, Inc. II Dec-15-2022
-
-