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TPLC
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show TPLC since
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Device
calibrator, primary
Product Code
JIS
Regulation Number
862.1150
Device Class
2
Premarket Reviews
Manufacturer
Decision
RANDOX LABORATORIES LIMITED
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2015
1
1
2016
1
1
2017
3
3
2018
7
7
2019
1
1
2020
1
1
2022
11
11
2024
1
1
Device Problems
MDRs with this Device Problem
Events in those MDRs
Calibration Problem
12
12
Low Test Results
8
8
High Test Results
3
3
Device Ingredient or Reagent Problem
1
1
High Readings
1
1
Incorrect, Inadequate or Imprecise Result or Readings
1
1
Improper or Incorrect Procedure or Method
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Known Impact Or Consequence To Patient
13
13
No Clinical Signs, Symptoms or Conditions
11
11
No Consequences Or Impact To Patient
1
1
Hematoma
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Abbott Laboratories
II
Apr-07-2022
2
Beckman Coulter Inc.
II
Nov-15-2016
3
Beckman Coulter Inc.
II
Dec-22-2012
4
Beckman Coulter Inc.
II
Jun-21-2011
5
Fujifilm Medical Systems U.S.A., Inc.
III
Jan-28-2021
6
Ortho Clinical Diagnostics Inc
II
Feb-15-2019
7
Sentinel CH SpA
III
Oct-06-2021
8
Siemens Healthcare Diagnostics, Inc
III
Aug-14-2013
9
Siemens Healthcare Diagnostics, Inc
II
Apr-15-2013
10
Siemens Healthcare Diagnostics, Inc.
III
Mar-15-2017
11
Siemens Healthcare Diagnostics, Inc.
III
Jan-29-2013
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