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TPLC
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Device
system, test, beta-2-microglobulin immunological
Product Code
JZG
Regulation Number
866.5630
Device Class
2
Premarket Reviews
Manufacturer
Decision
BECKMAN COULTER IRELAND INC.
SUBSTANTIALLY EQUIVALENT
1
SIEMENS HEALTHCARE DIAGNOSTICS
SUBSTANTIALLY EQUIVALENT
1
SIEMENS HEALTHCARE DIAGNOSTICS, INC.
SUBSTANTIALLY EQUIVALENT
1
THE BINDING SITE GROUP LTD
SUBSTANTIALLY EQUIVALENT
1
THE BINDING SITE, LTD.
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2015
50
50
2019
1
1
Device Problems
MDRs with this Device Problem
Events in those MDRs
Device Displays Incorrect Message
42
42
Nonstandard Device
9
9
Imprecision
8
8
Failure to Calibrate
6
6
Calibration Problem
2
2
Incorrect, Inadequate or Imprecise Result or Readings
1
1
Device Ingredient or Reagent Problem
1
1
Incorrect Or Inadequate Test Results
1
1
Device Operates Differently Than Expected
1
1
Low Test Results
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Known Impact Or Consequence To Patient
48
48
No Information
37
37
Recalls
Manufacturer
Recall Class
Date Posted
1
Siemens Healthcare Diagnostics, Inc.
II
Dec-29-2021
2
Siemens Healthcare Diagnostics, Inc.
II
Mar-01-2016
3
Siemens Healthcare Diagnostics, Inc.
II
Aug-22-2015
4
The Binding Site Group, Ltd.
II
Apr-03-2018
5
Tosoh Bioscience Inc
II
Jun-05-2018
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