• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search Back To Search Results
Device enzyme linked immunoabsorbent assay, rubella
Regulation Description Rubella virus serological reagents.
Product CodeLFX
Regulation Number 866.3510
Device Class 2


Premarket Reviews
ManufacturerDecision
ABBOTT
  SUBSTANTIALLY EQUIVALENT 7
BAYER
  SUBSTANTIALLY EQUIVALENT 3
BECKMAN COULTER
  SUBSTANTIALLY EQUIVALENT 1
BIOMERIEUX
  SUBSTANTIALLY EQUIVALENT 1
Bio-Rad Laboratories
  SUBSTANTIALLY EQUIVALENT 1
CORDIS CORP.
  SUBSTANTIALLY EQUIVALENT 1
DIAGNOSTIC PRODUCTS
  SUBSTANTIALLY EQUIVALENT 3
DIASORIN
  SUBSTANTIALLY EQUIVALENT 3
ORGANON-TEKNIKA
  SUBSTANTIALLY EQUIVALENT 2
ORTHO-CLINICAL
  SUBSTANTIALLY EQUIVALENT 1
ROCHE DIAGNOSTICS CORP.
  SUBSTANTIALLY EQUIVALENT 2
WAMPOLE LABORATORIES,LLC
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Calibration error 367
Device displays error message 348
False positive result 14
High test results 13
False negative result 9
Low test results 7
No Known Device Problem 3
Incorrect or inadequate test results 3
Year 2000 (Y2K) related problem 1
False reading from device non-compliance 1
Incorrect or inadequate result 1
Total Device Problems 767

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
Class I 0 0 0 0 0 0 0 0 0 0
Class II 1 0 0 1 3 0 0 0 0 0
Class III 0 1 0 2 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Abbott Laboratories III Sep-16-2008
2 Abbott Laboratories II Jul-11-2007
3 Bio-Rad Laboratories II May-19-2011
4 Bio-Rad Laboratories III Mar-02-2010
5 BioCheck Inc II Mar-11-2011
6 Diasorin Inc. III Mar-02-2010
7 Meridian Bioscience Inc II Nov-17-2011
8 Siemens Healthcare Diagnostics Inc. II Mar-10-2010

-
-