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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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New Search Show TPLC since Back To Search Results
Device system, test, beta-2-microglobulin immunological
Regulation Description Beta-2-microglobulin immunological test system.
Product CodeJZG
Regulation Number 866.5630
Device Class 2


Premarket Reviews
ManufacturerDecision
BECKMAN COULTER IRELAND INC.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Device Displays Incorrect Message 37
Imprecision 8
Low Test Results 1
Total Device Problems 46

Recalls
Manufacturer Recall Class Date Posted
1 Siemens Healthcare Diagnostics, Inc. II Mar-01-2016
2 Siemens Healthcare Diagnostics, Inc. II Aug-22-2015
3 The Binding Site Group, Ltd. II Apr-03-2018
4 Tosoh Bioscience Inc II Jun-05-2018

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