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TPLC
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show TPLC since
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2024
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Device
counter, differential cell
Product Code
GKZ
Regulation Number
864.5220
Device Class
2
Premarket Reviews
Manufacturer
Decision
ABBOTT LABORATORIES
SUBSTANTIALLY EQUIVALENT
2
AD ASTRA DIAGNOSTICS, INC.
SUBSTANTIALLY EQUIVALENT
1
ATHELAS INC.
SUBSTANTIALLY EQUIVALENT
1
BECKMAN COULTER
SE - WITH LIMITATIONS
1
SUBSTANTIALLY EQUIVALENT
2
BECKMAN COULTER, INC.
SUBSTANTIALLY EQUIVALENT
1
NANOENTEK, INC.
SUBSTANTIALLY EQUIVALENT
2
PIXCELL MEDICAL TECHNOLOGIES, LTD.
SUBSTANTIALLY EQUIVALENT
1
S.D. SIGHT DIAGNOSTICS LTD.
SUBSTANTIALLY EQUIVALENT
1
SIGHT DIAGNOSTICS LTD.
SUBSTANTIALLY EQUIVALENT
1
SYSMEX AMERICA, INC.
SUBSTANTIALLY EQUIVALENT
5
MDR Year
MDR Reports
MDR Events
2019
908
908
2020
342
342
2021
391
391
2022
198
198
2023
143
143
2024
31
31
Device Problems
MDRs with this Device Problem
Events in those MDRs
Incorrect, Inadequate or Imprecise Result or Readings
1361
1361
Fluid/Blood Leak
200
200
Low Test Results
142
142
High Test Results
59
59
Leak/Splash
38
38
Use of Device Problem
30
30
Adverse Event Without Identified Device or Use Problem
27
27
Smoking
22
22
Device Markings/Labelling Problem
16
16
Low Readings
14
14
Output Problem
13
13
Thermal Decomposition of Device
12
12
Contamination
10
10
Improper or Incorrect Procedure or Method
10
10
Patient Data Problem
7
7
Unintended Electrical Shock
5
5
Sparking
5
5
Fire
4
4
Incorrect Measurement
4
4
Mechanical Problem
4
4
Missing Information
4
4
Wrong Label
3
3
Contamination of Device Ingredient or Reagent
3
3
Unintended Movement
3
3
Insufficient Information
3
3
High Readings
3
3
Obstruction of Flow
2
2
Electrical Shorting
2
2
Device Contamination with Chemical or Other Material
2
2
Overheating of Device
2
2
Failure to Read Input Signal
2
2
Computer Software Problem
2
2
Device Handling Problem
2
2
Device Fell
2
2
Temperature Problem
1
1
Non Reproducible Results
1
1
Intermittent Communication Failure
1
1
Priming Problem
1
1
Missing Test Results
1
1
Sharp Edges
1
1
Appropriate Term/Code Not Available
1
1
Data Problem
1
1
Break
1
1
Display or Visual Feedback Problem
1
1
Electrical /Electronic Property Problem
1
1
False Negative Result
1
1
Retraction Problem
1
1
Device Remains Activated
1
1
Difficult to Remove
1
1
Installation-Related Problem
1
1
Material Integrity Problem
1
1
Mechanical Jam
1
1
Fail-Safe Problem
1
1
Blocked Connection
1
1
Contamination /Decontamination Problem
1
1
Defective Component
1
1
Arcing
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Consequences Or Impact To Patient
962
962
No Clinical Signs, Symptoms or Conditions
781
781
No Known Impact Or Consequence To Patient
125
125
No Patient Involvement
123
123
Test Result
10
10
Needle Stick/Puncture
6
6
Injury
5
5
No Code Available
5
5
Eye Injury
4
4
Exposure to Body Fluids
3
3
Misdiagnosis
3
3
No Information
2
2
Electric Shock
2
2
Unspecified Blood or Lymphatic problem
2
2
Muscle/Tendon Damage
2
2
Insufficient Information
2
2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
1
1
Swelling/ Edema
1
1
Unspecified Eye / Vision Problem
1
1
Cancer
1
1
Lymphoma
1
1
Chemical Exposure
1
1
Abdominal Pain
1
1
Fall
1
1
Fever
1
1
Head Injury
1
1
Pain
1
1
Shock
1
1
Fracture, Arm
1
1
Reaction
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Abbott Laboratories
II
Dec-21-2023
2
Abbott Laboratories
II
Oct-22-2019
3
Abbott Laboratories
II
Mar-29-2019
4
Beckman Coulter Inc.
I
May-23-2019
5
Beckman Coulter, Inc.
II
Nov-22-2019
6
Becton, Dickinson and Company, BD Biosciences
II
Nov-03-2022
7
Clinical Diagnostic Solutions, Inc.
II
Feb-05-2020
8
SIGHT DIAGNOSTICS LTD
II
Jul-27-2022
9
SIGHT DIAGNOSTICS LTD
II
Apr-21-2022
10
SIGHT DIAGNOSTICS LTD
II
Sep-22-2021
11
Siemens Healthcare Diagnostics, Inc.
II
Apr-09-2021
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