Quick Links: Skip to main page content
Skip to Search
Skip to Topics Menu
Skip to Common Links
U.S. Food & Drug Administration
Follow FDA
En Español
Search FDA
Home
Food
Drugs
Medical Devices
Radiation-Emitting Products
Vaccines, Blood & Biologics
Animal & Veterinary
Cosmetics
Tobacco Products
TPLC - Total Product Life Cycle
FDA Home
medical devices
databases
-
510(k)
|
DeNovo
|
Registration & Listing
|
Adverse Events
|
Recalls
|
PMA
|
HDE
|
Classification
|
Standards
CFR Title 21
|
Radiation-Emitting Products
|
X-Ray Assembler
|
Medsun Reports
|
CLIA
|
TPLC
New Search
show TPLC since
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
Back to Search Results
Device
test, hiv detection
Product Code
MZF
Regulation Number
866.3956
Device Class
2
Premarket Reviews
Manufacturer
Decision
SUBSTANTIALLY EQUIVALENT
1
BECKMAN COULTER, INC.
SUBSTANTIALLY EQUIVALENT
1
MEDMIRA LABORATORIES INC.
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2014
49
49
2015
74
74
2016
79
79
2017
135
135
2018
580
580
2019
154
154
2020
66
66
2021
65
65
2022
115
115
2023
88
88
2024
18
18
Device Problems
MDRs with this Device Problem
Events in those MDRs
False Positive Result
811
811
False Negative Result
310
310
Incorrect, Inadequate or Imprecise Result or Readings
113
113
Low Test Results
57
57
Adverse Event Without Identified Device or Use Problem
44
44
High Test Results
27
27
Non Reproducible Results
19
19
Incorrect Or Inadequate Test Results
17
17
No Apparent Adverse Event
14
14
Calibration Error
13
13
Leak/Splash
11
11
Improper or Incorrect Procedure or Method
6
6
Use of Device Problem
5
5
Appropriate Term/Code Not Available
4
4
False Reading From Device Non-Compliance
2
2
Unable to Obtain Readings
2
2
Insufficient Information
2
2
Mechanical Problem
1
1
Output Problem
1
1
Wrong Label
1
1
Inadequate or Insufficient Training
1
1
Off-Label Use
1
1
Human Factors Issue
1
1
Device Operates Differently Than Expected
1
1
Illegible Information
1
1
Patient-Device Incompatibility
1
1
Low Readings
1
1
Data Problem
1
1
Failure to Calibrate
1
1
Erratic Results
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Known Impact Or Consequence To Patient
775
775
No Information
453
453
No Clinical Signs, Symptoms or Conditions
266
266
No Consequences Or Impact To Patient
147
147
Pregnancy
88
88
No Patient Involvement
69
69
No Code Available
29
29
HIV, Human Immunodeficiency Virus
23
23
Insufficient Information
19
19
Misdiagnosis
16
16
Test Result
10
10
Positive antinuclear antibodies (ANA)
8
8
Exposure to Body Fluids
7
7
Missing Value Reason
5
5
Cancer
5
5
Needle Stick/Puncture
4
4
Eye Injury
4
4
Anxiety
3
3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
3
3
Confusion/ Disorientation
2
2
Chemical Exposure
2
2
Hepatitis
2
2
Herpes
2
2
Death
2
2
Unspecified Infection
2
2
Inflammation
1
1
Overdose
1
1
Pain
1
1
Venereal Disease
1
1
Vomiting
1
1
Diarrhea
1
1
Emotional Changes
1
1
Bradycardia
1
1
Hypersensitivity/Allergic reaction
1
1
Hemorrhage/Bleeding
1
1
Irregular Pulse
1
1
Sleep Dysfunction
1
1
Reaction
1
1
Numbness
1
1
Viral Infection
1
1
-
-