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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device system, test, rheumatoid factor
Product CodeDHR
Regulation Number 866.5775
Device Class 2


Premarket Reviews
ManufacturerDecision
IMMCO DIAGNOSTICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
INOVA DIAGNOSTICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
KAMIYA BIOMEDICAL COMPANY
  SUBSTANTIALLY EQUIVALENT 1
ORGENTEC DIAGNOSTIKA GMBH
  SUBSTANTIALLY EQUIVALENT 1
PHADIA AB
  SUBSTANTIALLY EQUIVALENT 1
PHADIA US INC.
  SUBSTANTIALLY EQUIVALENT 1
SQI DIAGNOSTICS SYSTEMS
  SUBSTANTIALLY EQUIVALENT 1
THE BINDING SITE GROUP LTD.
  SUBSTANTIALLY EQUIVALENT 1
THE BINDING SITE GROUP, LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2018 1 1
2024 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect, Inadequate or Imprecise Result or Readings 1 1
Suction Problem 1 1
Low Test Results 1 1
Non Reproducible Results 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 2 2
No Known Impact Or Consequence To Patient 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Beckman Coulter Inc. II Oct-01-2012
2 Beckman Coulter Inc. II Mar-08-2012
3 Beckman Coulter Inc. II Jul-27-2011
4 Beckman Coulter Inc. II Mar-22-2011
5 Hycor Biomedical Inc II Aug-06-2019
6 Hycor Biomedical Inc II Jul-30-2019
7 Ortho-Clinical Diagnostics II Jan-11-2012
8 Phadia Ab II Jul-01-2019
9 Randox Laboratories Ltd. II Nov-04-2019
10 Stanbio Laboratory, LP II Mar-15-2018
11 The Binding Site Group, Ltd. II May-22-2020
12 The Binding Site Group, Ltd. II Mar-13-2020
13 The Binding Site Group, Ltd. II Feb-08-2018
14 Thera Test Laboratories, Inc. II May-14-2012
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