TPLC - Total Product Life Cycle

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Device	radioimmunoassay, thyroid-stimulating hormone
Regulation Description	Thyroid stimulating hormone test system.
Product Code	JLW
Regulation Number	862.1690
Device Class	2

Premarket Reviews
Manufacturer	Decision
BECKMAN COULTER, INC.
	SUBSTANTIALLY EQUIVALENT	1
GENALYTE, INC.
	SUBSTANTIALLY EQUIVALENT	1
SIEMENS HEALTHCARE DIAGNOSTICS
	SUBSTANTIALLY EQUIVALENT	1
SIEMENS HEALTHCARE DIAGNOSTICS INC.
	SUBSTANTIALLY EQUIVALENT	1
SIEMENS HEALTHCARE DIAGNOSTICS, INC.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Low Test Results	428	434
High Test Results	339	356
Non Reproducible Results	55	58
Incorrect, Inadequate or Imprecise Result or Readings	46	47
Adverse Event Without Identified Device or Use Problem	13	13
No Apparent Adverse Event	8	8
Insufficient Information	7	7
Incorrect Measurement	7	7
Chemical Problem	5	5
High Readings	4	4
Material Integrity Problem	2	2
Output Problem	2	2
Appropriate Term/Code Not Available	2	2
Cross Reactivity	1	1
False Positive Result	1	1
Mechanical Problem	1	1
No Device Output	1	1
Low Readings	1	1
Device Ingredient or Reagent Problem	1	1
Improper Chemical Reaction	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	664	672
No Consequences Or Impact To Patient	76	76
No Known Impact Or Consequence To Patient	61	78
Insufficient Information	8	8
No Patient Involvement	4	4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	4	4
Test Result	2	3
Diarrhea	1	1
Hypothermia	1	1
Full thickness (Third Degree) Burn	1	1
Hormonal Imbalance	1	1
Polymyositis	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Beckman Coulter, Inc.	II	Jun-06-2025
2	Beckman Coulter, Inc.	II	Jun-05-2025
3	Beckman Coulter, Inc.	II	Oct-16-2024
4	Qualigen Inc	II	Oct-08-2024
5	Siemens Healthcare Diagnostics, Inc.	II	Jun-09-2022
6	Siemens Healthcare Diagnostics, Inc.	II	Jul-07-2021
7	Siemens Healthcare Diagnostics, Inc.	II	Nov-19-2020