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TPLC
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2024
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Device
system, test, automated blood grouping and antibody
Product Code
KSZ
Regulation Number
864.9175
Device Class
2
Premarket Reviews
Manufacturer
Decision
BECKMAN COULTER, INC.
SUBSTANTIALLY EQUIVALENT
1
BIO RAD MEDICAL DIAGNOSTICS GMBH
SUBSTANTIALLY EQUIVALENT
2
BIO-RAD MEDICAL DIAGNOSTICS GMBH
SUBSTANTIALLY EQUIVALENT
17
DIAGNOSTIC GRIFOLS, S. A.
SUBSTANTIALLY EQUIVALENT
18
IMMUCOR, INC.
SUBSTANTIALLY EQUIVALENT
19
MICRO TYPING SYSTEMS INC.
SUBSTANTIALLY EQUIVALENT
5
OLYMPUS AMERICA INC., DIAGNOSTIC SYSTEMS DIVISION
SUBSTANTIALLY EQUIVALENT
1
ORTHO-CLINICAL DIAGNOSTICS, INC.
SUBSTANTIALLY EQUIVALENT
8
STRATEC BIOMEDICAL UK LIMITED
SUBSTANTIALLY EQUIVALENT
2
MDR Year
MDR Reports
MDR Events
2014
526
526
2015
485
485
2016
620
620
2017
626
626
2018
686
686
2019
298
301
2020
75
142
2021
76
213
2022
78
156
2023
151
179
2024
13
23
Device Problems
MDRs with this Device Problem
Events in those MDRs
False Negative Result
2236
2520
Incorrect, Inadequate or Imprecise Result or Readings
416
454
False Positive Result
415
450
Incorrect Or Inadequate Test Results
222
222
Device Operates Differently Than Expected
107
107
Adverse Event Without Identified Device or Use Problem
85
85
Defective Component
50
50
Defective Device
45
45
Display Difficult to Read
40
40
Improper or Incorrect Procedure or Method
36
36
Output Problem
19
19
Computer Software Problem
13
13
Incorrect Measurement
12
12
Device Displays Incorrect Message
11
11
Insufficient Information
10
10
Data Problem
9
9
Device Expiration Issue
9
9
Unexpected Therapeutic Results
7
7
Patient-Device Incompatibility
7
7
Improper Device Output
7
7
False Reading From Device Non-Compliance
7
7
Inadequate Instructions for Healthcare Professional
7
7
Device Alarm System
7
7
Patient Data Problem
7
7
Inaccurate Information
7
7
Break
6
6
Use of Device Problem
6
6
Component Missing
6
6
Device Ingredient or Reagent Problem
5
5
Leak/Splash
5
5
Non Reproducible Results
5
13
Device Maintenance Issue
4
4
Fluid/Blood Leak
4
4
Poor Quality Image
4
4
Alarm Not Visible
4
4
Component Falling
4
4
Improper Chemical Reaction
4
4
Device Markings/Labelling Problem
3
3
Application Program Problem
3
3
Smoking
3
3
Contamination
3
3
Use of Incorrect Control/Treatment Settings
3
3
Mechanical Problem
3
5
Display or Visual Feedback Problem
3
3
Electrical /Electronic Property Problem
3
3
Missing Test Results
3
3
Naturally Worn
3
3
Misassembly by Users
3
3
Output below Specifications
2
2
Application Program Problem: Medication Error
2
2
Failure to Power Up
2
2
Nonstandard Device
2
2
Occlusion Within Device
2
2
No Display/Image
2
2
Bent
2
2
Device Reprocessing Problem
2
2
Failure to Read Input Signal
2
2
Self-Activation or Keying
2
2
High Test Results
2
2
Sparking
2
2
Expiration Date Error
2
2
Connection Problem
2
2
Device Contamination with Chemical or Other Material
2
2
Compatibility Problem
2
2
Incorrect Device Or Component Shipped
2
2
Maintenance Does Not Comply To Manufacturers Recommendations
1
1
Material Twisted/Bent
1
1
Optical Problem
1
1
Computer Operating System Problem
1
1
Fail-Safe Problem
1
1
Failure of Device to Self-Test
1
1
Failure to Obtain Sample
1
1
Low Readings
1
1
Failure to Deliver
1
1
Inappropriate/Inadequate Shock/Stimulation
1
1
Inadequate or Insufficient Training
1
1
Complete Blockage
1
1
Coagulation in Device or Device Ingredient
1
1
Burst Container or Vessel
1
1
Calibration Error
1
1
Circuit Failure
1
1
Air Leak
1
1
Crack
1
1
Cross Reactivity
1
1
Positioning Failure
1
1
Disassembly
1
1
Device Emits Odor
1
1
Output above Specifications
1
1
Overheating of Device
1
1
Power Conditioning Problem
1
1
Product Quality Problem
1
1
Misassembled
1
1
Image Display Error/Artifact
1
1
Imprecision
1
1
Excess Flow or Over-Infusion
1
1
Device Handling Problem
1
1
Noise, Audible
1
1
Physical Resistance/Sticking
1
1
Unintended Electrical Shock
1
1
No Apparent Adverse Event
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Known Impact Or Consequence To Patient
2237
2253
No Consequences Or Impact To Patient
774
774
No Clinical Signs, Symptoms or Conditions
299
435
No Information
82
82
Reaction
53
53
Test Result
45
52
No Code Available
40
40
Insufficient Information
30
194
Patient Problem/Medical Problem
13
13
Injury
12
12
No Patient Involvement
11
11
Fever
8
8
Hemolysis
7
7
Laceration(s)
6
6
Death
5
5
Headache
5
5
Low Blood Pressure/ Hypotension
4
4
Pain
4
4
Complaint, Ill-Defined
4
4
Jaundice
4
4
Chills
3
3
Electric Shock
3
3
Exposure to Body Fluids
3
3
Hemorrhage/Bleeding
2
2
Chemical Exposure
2
2
Therapeutic Effects, Unexpected
2
2
Venipuncture
2
2
Nausea
1
1
Overdose
1
1
Urticaria
1
1
Anxiety
1
1
Blood Loss
1
1
Hematuria
1
1
Missed Dose
1
1
Needle Stick/Puncture
1
1
Hyperbilirubinemia
1
1
Hypoxia
1
1
Pneumonia
1
1
Rash
1
1
Respiratory Distress
1
1
Tachycardia
1
1
Bruise/Contusion
1
1
Airway Obstruction
1
1
Autoimmune Reaction
1
1
Hearing Loss
1
1
Bone Fracture(s)
1
1
Alteration In Body Temperature
1
1
Pregnancy
1
1
Unspecified Tissue Injury
1
1
Reaction to Medicinal Component of Device
1
1
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