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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device antinuclear antibody, antigen, control
Product CodeLKJ
Regulation Number 866.5100
Device Class 2


Premarket Reviews
ManufacturerDecision
BIO-RAD LABORATORIES
  SUBSTANTIALLY EQUIVALENT 1
PHADIA AB
  SUBSTANTIALLY EQUIVALENT 1
PHADIA US INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2017 2 2
2018 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Nonstandard Device 2 2
Incorrect Or Inadequate Test Results 1 1
Expiration Date Error 1 1
Insufficient Information 1 1
Inadequate Instructions for Healthcare Professional 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 2 2
No Information 1 1
No Code Available 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Bio-Rad Laboratories Inc II Mar-02-2011
2 Bio-Rad Laboratories Inc II Mar-02-2011
3 Bio-Rad Laboratories Inc III Dec-13-2010
4 Bio-Rad Laboratories Inc II Dec-13-2010
5 Bio-Rad Laboratories Inc II Dec-13-2010
6 Bio-Rad Laboratories Inc II Dec-06-2010
7 Bio-Rad Laboratories, Inc. II Oct-08-2021
8 Euro Diagnostica AB III Oct-11-2018
9 Euro Diagnostica AB III Aug-23-2018
10 Euro Diagnostica AB II Mar-08-2018
11 Euro Diagnostica AB II Dec-20-2017
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