Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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 show TPLC since Back to Search Results
Device enzyme linked immunoabsorbent assay, cytomegalovirus
Product CodeLFZ
Regulation Number 866.3175
Device Class 2


Premarket Reviews
ManufacturerDecision
ABBOTT LABORATORIES
  SUBSTANTIALLY EQUIVALENT 1
DIASORIN INC.
  SUBSTANTIALLY EQUIVALENT 1
ROCHE DIAGNOSTICS
  SUBSTANTIALLY EQUIVALENT 4
SIEMENS HEALTHCARE DIAGNOSTICS, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 3 3
2015 7 7
2016 14 14
2017 13 13
2018 9 9
2019 10 10
2020 7 7
2021 23 23
2022 11 11
2023 36 36
2024 22 22

Device Problems MDRs with this Device Problem Events in those MDRs
False Positive Result 38 38
Low Test Results 36 36
False Negative Result 32 32
High Test Results 19 19
Incorrect, Inadequate or Imprecise Result or Readings 14 14
Unable to Obtain Readings 8 8
Non Reproducible Results 6 6
Component Missing 4 4
Appropriate Term/Code Not Available 4 4
Incorrect Or Inadequate Test Results 1 1
Device Displays Incorrect Message 1 1
Adverse Event Without Identified Device or Use Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 91 91
No Known Impact Or Consequence To Patient 33 33
No Consequences Or Impact To Patient 28 28
No Patient Involvement 3 3

Recalls
Manufacturer Recall Class Date Posted
1 Abbott Laboratories II Apr-15-2009
2 Bio-Rad Laboratories, Inc. II Dec-06-2022
3 BioMerieux SA II Feb-14-2017
4 Diamedix Corporation II May-17-2016
-
-