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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device enzyme immunoassay, non-radiolabeled, total thyroxine
Product CodeKLI
Regulation Number 862.1700
Device Class 2


Premarket Reviews
ManufacturerDecision
ALFA WASSERMANN
  SUBSTANTIALLY EQUIVALENT 1
ORTHO-CLINICAL DIAGNOSTICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
SIEMENS HEALTHCARE DIAGNOSTICS INC.
  SUBSTANTIALLY EQUIVALENT 1
WALLAC OY, A SUBSIDIARY OF PERKINELMER, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 5 5
2018 3 3
2019 1 1
2021 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect, Inadequate or Imprecise Result or Readings 3 3
Incorrect Or Inadequate Test Results 3 3
High Test Results 2 2
Low Test Results 2 2
Low Readings 1 1
False Positive Result 1 1
Nonstandard Device 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 6 6
No Clinical Signs, Symptoms or Conditions 3 3
No Consequences Or Impact To Patient 3 3

Recalls
Manufacturer Recall Class Date Posted
1 Beckman Coulter Inc. II Aug-16-2011
2 Beckman Coulter Inc. II Apr-12-2011
3 Beckman Coulter, Inc. II Mar-15-2024
4 BioCheck, Inc. II Nov-10-2021
5 DRG International, Inc. II Nov-29-2021
6 ORTHO-CLINICAL DIAGNOSTICS II Jul-29-2016
7 Ortho Clinical Diagnostics III Apr-30-2020
8 Ortho-Clinical Diagnostics II May-21-2014
9 Siemens Healthcare Diagnostics, Inc. II May-04-2018
10 Tosoh Bioscience Inc II Jun-05-2018
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