• 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, thyroid autoantibody
Regulation Description Thyroid autoantibody immunological test system.
Product CodeJZO
Regulation Number 866.5870
Device Class 2


Premarket Reviews
ManufacturerDecision
BECKMAN COULTER INC.
  SUBSTANTIALLY EQUIVALENT 1
BECKMAN COULTER, INC.
  SUBSTANTIALLY EQUIVALENT 1
ROCHE DIAGNOSTICS
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2020 17 17
2021 19 19
2022 25 25
2023 33 33
2024 30 30
2025 10 10

Device Problems MDRs with this Device Problem Events in those MDRs
High Test Results 74 74
Low Test Results 33 33
Non Reproducible Results 24 24
Incorrect, Inadequate or Imprecise Result or Readings 13 13
Incorrect Measurement 5 5
False Negative Result 2 2
Manufacturing, Packaging or Shipping Problem 2 2
False Positive Result 2 2
Output Problem 1 1
Insufficient Information 1 1
High Readings 1 1
Precipitate in Device or Device Ingredient 1 1
Low Readings 1 1
Failure to Calibrate 1 1
No Device Output 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 115 115
No Consequences Or Impact To Patient 14 14
No Known Impact Or Consequence To Patient 5 5

Recalls
Manufacturer Recall Class Date Posted
1 Abbott Ireland Limited III Jun-08-2023
2 Roche Diagnostics Operations, Inc. II Sep-17-2020
3 Siemens Healthcare Diagnostics, Inc. II Sep-27-2024
4 Siemens Healthcare Diagnostics, Inc. II May-23-2024
5 Siemens Healthcare Diagnostics, Inc. II Sep-27-2022
6 Tosoh Bioscience Inc II Mar-08-2021
-
-