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 INC.
	SUBSTANTIALLY EQUIVALENT	1
1. K222116 Atellica® CI Analyzer, Atellica® IMThyroid Stimul ...
SIEMENS HEALTHCARE DIAGNOSTICS, INC.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Low Test Results	416	422
High Test Results	321	338
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
High Readings	4	4
Chemical Problem	4	4
Output Problem	2	2
Appropriate Term/Code Not Available	2	2
Material Integrity Problem	2	2
Device Ingredient or Reagent Problem	1	1
Improper Chemical Reaction	1	1
Low Readings	1	1
Mechanical Problem	1	1
No Device Output	1	1
Cross Reactivity	1	1
False Positive Result	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	638	646
No Consequences Or Impact To Patient	76	76
No Known Impact Or Consequence To Patient	61	78
Insufficient Information	8	8
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	4	4
No Patient Involvement	4	4
Test Result	2	3
Diarrhea	1	1
Hypothermia	1	1
Polymyositis	1	1
Hormonal Imbalance	1	1
Full thickness (Third Degree) Burn	1	1

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