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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device antibody igm,if, cytomegalovirus virus
Product CodeLKQ
Regulation Number 866.3175
Device Class 2


Premarket Reviews
ManufacturerDecision
SIEMENS HEALTHCARE DIAGNOSTICS
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2015 2 2
2016 29 29
2017 14 14
2018 8 8
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
Device Ingredient or Reagent Problem 27 27
Incorrect Or Inadequate Test Results 14 14
False Negative Result 11 11
Incorrect, Inadequate or Imprecise Result or Readings 9 9
Adverse Event Without Identified Device or Use Problem 7 7
Low Test Results 2 2
False Positive Result 1 1
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 41 41
No Patient Involvement 17 17
No Consequences Or Impact To Patient 4 4

Recalls
Manufacturer Recall Class Date Posted
1 Biomerieux Inc II Apr-10-2021
2 QIAGEN Gaithersburg, Inc. II May-14-2013
3 Quest International, Inc. III Jan-23-2012
4 Siemens Healthcare Diagnostics, Inc. II Oct-27-2016
5 bioMerieux, Inc. II Mar-14-2022
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