TPLC - Total Product Life Cycle

show TPLC since

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	1
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	1108	1109
False Negative Result	260	260
Non Reproducible Results	101	101
Incorrect, Inadequate or Imprecise Result or Readings	67	67
Output Problem	22	22
Leak/Splash	11	11
Erratic Results	9	9
High Test Results	6	6
Incorrect Measurement	5	5
Low Test Results	5	5
Adverse Event Without Identified Device or Use Problem	4	4
Contamination /Decontamination Problem	2	2
Use of Device Problem	2	2
Compatibility Problem	1	1
Mechanical Problem	1	1
Off-Label Use	1	1
Insufficient Information	1	1
Wrong Label	1	1
Unable to Obtain Readings	1	1
Calibration Problem	1	1
Device Handling 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	1471	1472
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