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 antibody igm,if, cytomegalovirus virus
Product CodeLKQ
Regulation Number 866.3175
Device Class 2

MDR Year MDR Reports MDR Events
2019 9 9
2021 68 68
2022 17 17

Device Problems MDRs with this Device Problem Events in those MDRs
Failure to Calibrate 78 78
False Negative Result 6 6
Incorrect, Inadequate or Imprecise Result or Readings 6 6
Low Test Results 2 2
Adverse Event Without Identified Device or Use Problem 2 2
Incorrect Measurement 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 85 85
No Known Impact Or Consequence To Patient 5 5
No Consequences Or Impact To Patient 2 2
No Patient Involvement 2 2

Recalls
Manufacturer Recall Class Date Posted
1 Biomerieux Inc II Apr-10-2021
2 bioMerieux, Inc. II Mar-14-2022
-
-