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 radioimmunoassay, thyroid-stimulating hormone
Product CodeJLW
Regulation Number 862.1690
Device Class 2


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

MDR Year MDR Reports MDR Events
2018 249 249
2019 216 260
2020 145 163
2021 146 146
2022 137 137
2023 57 57

Device Problems MDRs with this Device Problem Events in those MDRs
Low Test Results 423 438
High Test Results 334 370
Non Reproducible Results 72 83
Incorrect, Inadequate or Imprecise Result or Readings 53 53
Incorrect Or Inadequate Test Results 28 28
Adverse Event Without Identified Device or Use Problem 17 17
No Apparent Adverse Event 14 14
High Readings 13 13
Device Damaged Prior to Use 11 11
Unable to Obtain Readings 11 11
Low Readings 7 7
Insufficient Information 4 4
Incorrect Measurement 4 4
Appropriate Term/Code Not Available 2 2
Device Operates Differently Than Expected 2 2
Device Ingredient or Reagent Problem 1 1
Mechanical Problem 1 1
Leak/Splash 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 334 334
No Consequences Or Impact To Patient 294 294
No Known Impact Or Consequence To Patient 292 353
No Patient Involvement 13 13
Insufficient Information 6 6
Test Result 5 6
No Code Available 4 4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 3 3
Hormonal Imbalance 1 1
Full thickness (Third Degree) Burn 1 1
Palpitations 1 1
Underdose 1 1
Hypothermia 1 1
Polymyositis 1 1
Thyroid Problems 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Abbott Ireland Diagnostics Division II Dec-22-2018
2 Clinical Diagnostic Systems III Apr-10-2018
3 Ortho Clinical Diagnostics Inc II Oct-03-2018
4 Ortho-Clinical Diagnostics II Oct-05-2018
5 Roche Diagnostics Operations, Inc. II Oct-04-2019
6 Siemens Healthcare Diagnostics, Inc. II Jun-09-2022
7 Siemens Healthcare Diagnostics, Inc. II Jul-07-2021
8 Siemens Healthcare Diagnostics, Inc. II Nov-19-2020
9 Siemens Healthcare Diagnostics, Inc. II May-09-2019
10 Siemens Healthcare Diagnostics, Inc. II Jun-01-2018
11 Siemens Healthcare Diagnostics, Inc. II May-04-2018
12 Tosoh Bioscience Inc II Jun-05-2018
-
-