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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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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
Device ingredient or reagent issue 32
False positive result 14
High test results 14
False negative result 10
Low test results 7
Incorrect or inadequate test results 3
No Known Device Problem 3
No Information 1
False reading from device non-compliance 1
Incorrect or inadequate result 1
Year 2000 (Y2K) related problem 1
Total Device Problems 802

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 1
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
9 Siemens Healthcare Diagnostics, Inc. II Oct-13-2016

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