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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device system, test, beta-2-microglobulin immunological
Product CodeJZG
Regulation Number 866.5630
Device Class 2


Premarket Reviews
ManufacturerDecision
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
Device Ingredient or Reagent Problem 1 1
Device Operates Differently Than Expected 1 1
Incorrect Or Inadequate Test Results 1 1
Low Test Results 1 1
Incorrect, Inadequate or Imprecise Result or Readings 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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