TPLC - Total Product Life Cycle

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Device	enzyme linked immunoabsorbent assay, toxoplasma gondii
Product Code	LGD
Regulation Number	866.3780
Device Class	2

Premarket Reviews
Manufacturer	Decision
ABBOTT LABORATORIES
	SUBSTANTIALLY EQUIVALENT	1
BIO-RAD LABORATORIES
	SUBSTANTIALLY EQUIVALENT	1
BIOMERIEUX, INC.
	SUBSTANTIALLY EQUIVALENT	1
DIASORIN, INC.
	SUBSTANTIALLY EQUIVALENT	2
ROCHE 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
False Positive Result	319	319
Adverse Event Without Identified Device or Use Problem	221	221
High Test Results	165	165
Mechanical Problem	85	85
Incorrect, Inadequate or Imprecise Result or Readings	56	56
No Apparent Adverse Event	42	42
False Negative Result	35	35
Incorrect Or Inadequate Test Results	26	26
Low Test Results	12	12
Non Reproducible Results	11	11
Insufficient Information	8	8
Device Issue	5	5
Device Operational Issue	2	2
Human Factors Issue	1	1
Power Problem	1	1
Low Readings	1	1
Device Displays Incorrect Message	1	1
Implant Mobility NOS (Not otherwise specified)	1	1
Component Falling	1	1
Contamination	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Known Impact Or Consequence To Patient	488	488
No Clinical Signs, Symptoms or Conditions	279	279
No Consequences Or Impact To Patient	190	190
No Patient Involvement	9	9
Pregnancy	4	4
No Code Available	3	3