TPLC - Total Product Life Cycle

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Device	test, hiv detection
Regulation Description	Human immunodeficiency virus (HIV) serological diagnostic and/or supplemental test.
Product Code	MZF
Regulation Number	866.3956
Device Class	2

Premarket Reviews
Manufacturer	Decision

	SUBSTANTIALLY EQUIVALENT	1
BECKMAN COULTER, INC.
	SUBSTANTIALLY EQUIVALENT	1
DIASORIN INC.
	SUBSTANTIALLY EQUIVALENT	2
MEDMIRA LABORATORIES 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	1268	1269
False Negative Result	268	268
Non Reproducible Results	111	111
Incorrect, Inadequate or Imprecise Result or Readings	72	72
Output Problem	22	22
Leak/Splash	11	11
Erratic Results	9	9
High Test Results	6	6
Low Test Results	6	6
Incorrect Measurement	5	5
Adverse Event Without Identified Device or Use Problem	4	4
Insufficient Information	2	2
Contamination /Decontamination Problem	2	2
Use of Device Problem	2	2
Improper or Incorrect Procedure or Method	2	2
Compatibility Problem	1	1
Mechanical Problem	1	1
Off-Label Use	1	1
Wrong Label	1	1
Unable to Obtain Readings	1	1
Calibration Problem	1	1
Computer Operating System Problem	1	1
Device Handling Problem	1	1
Installation-Related Problem	1	1
Illegible Information	1	1
No Device Output	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	1644	1645
Insufficient Information	39	39
Exposure to Body Fluids	4	4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	3	3
Viral Infection	3	3
Confusion/ Disorientation	2	2
Anxiety	2	2
Needle Stick/Puncture	1	1
No Consequences Or Impact To Patient	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Mckesson Medical-Surgical Inc. Corporate Office	II	May-27-2025