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TPLC
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show TPLC since
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Device
system, hemoglobin, automated
Product Code
GKR
Regulation Number
864.5620
Device Class
2
Premarket Reviews
Manufacturer
Decision
ACON LABORATORIES, INC.
SUBSTANTIALLY EQUIVALENT
1
DIASPECT MEDICAL GMBH
SUBSTANTIALLY EQUIVALENT
1
EKF-DIAGNOSTIC GMBH
SUBSTANTIALLY EQUIVALENT
4
HEMOCUE AB
SUBSTANTIALLY EQUIVALENT
2
IMMUNOSTICS, INC.
SUBSTANTIALLY EQUIVALENT
2
MEC DYNAMICS CORP
SUBSTANTIALLY EQUIVALENT
1
STANBIO LABORATORY
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2014
31
31
2015
19
19
2016
9
9
2019
9
9
2020
1
1
2021
1
1
2022
1
1
2024
1
1
Device Problems
MDRs with this Device Problem
Events in those MDRs
Improper or Incorrect Procedure or Method
10
10
Incorrect, Inadequate or Imprecise Result or Readings
8
8
Solder Joint Fracture
8
8
Patient Data Problem
8
8
Computer Software Problem
8
8
Incorrect Or Inadequate Test Results
7
7
Device Operates Differently Than Expected
7
7
High Test Results
5
5
Maintenance Does Not Comply To Manufacturers Recommendations
4
4
Shelf Life Exceeded
3
3
Data Problem
3
3
Low Test Results
3
3
No Display/Image
2
2
Adverse Event Without Identified Device or Use Problem
2
2
Device Handling Problem
2
2
Use of Incorrect Control/Treatment Settings
2
2
Device Displays Incorrect Message
2
2
Incorrect Measurement
2
2
Improper Device Output
1
1
Mechanical Problem
1
1
Output Problem
1
1
Device Markings/Labelling Problem
1
1
Display Difficult to Read
1
1
Application Program Problem
1
1
Insufficient Information
1
1
Misassembly by Users
1
1
Display or Visual Feedback Problem
1
1
Device Issue
1
1
False Positive Result
1
1
Low Readings
1
1
Product Quality Problem
1
1
Device Reprocessing Problem
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Known Impact Or Consequence To Patient
43
43
No Consequences Or Impact To Patient
24
24
Pulmonary Dysfunction
1
1
No Code Available
1
1
Abnormal Blood Gases
1
1
Anemia
1
1
Cardiac Arrest
1
1
Missing Value Reason
1
1
Loss of consciousness
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Hemo Cue, Inc.
II
Mar-30-2011
2
HemoCue AB
II
Oct-29-2013
3
ITC-Nexus Dx, Inc.
II
Mar-31-2011
4
Siemens Healthcare Diagnostics, Inc.
II
Aug-24-2018
5
Stanbio Laboratory, LP
II
Aug-24-2018
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