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TPLC
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Device
mixture, hematology quality control
Product Code
JPK
Regulation Number
864.8625
Device Class
2
Premarket Reviews
Manufacturer
Decision
BECKMAN COULTER, INC.
SUBSTANTIALLY EQUIVALENT
5
BIO-RAD LABORATORIES
SUBSTANTIALLY EQUIVALENT
1
R & D SYSTEMS, INC.
SUBSTANTIALLY EQUIVALENT
5
STRECK
SUBSTANTIALLY EQUIVALENT
8
MDR Year
MDR Reports
MDR Events
2014
1
1
2019
1
1
2020
1
1
2021
1
1
2023
2
2
Device Problems
MDRs with this Device Problem
Events in those MDRs
Incorrect, Inadequate or Imprecise Result or Readings
3
3
Insufficient Information
1
1
Adverse Event Without Identified Device or Use Problem
1
1
Coagulation in Device or Device Ingredient
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
3
3
No Known Impact Or Consequence To Patient
1
1
Eye Injury
1
1
No Consequences Or Impact To Patient
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Becton, Dickinson and Company, BD Biosciences
II
Dec-10-2020
2
Clinical Diagnostic Solutions
II
Apr-09-2014
3
Clinical Diagnostic Solutions
III
Nov-05-2012
4
Clinical Diagnostic Solutions
III
Nov-02-2012
5
Horiba Instruments, Inc dba Horiba Medical
III
Nov-21-2012
6
Medline Industries Inc
II
Mar-12-2021
7
Primus Corporation dba Trinity Biotech
III
Dec-01-2022
8
Quantimetrix Corporation
II
Jan-17-2009
9
R & D Systems, Inc.
III
Jan-19-2023
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