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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, cytomegalovirus
Product CodeLFZ
Regulation Number 866.3175
Device Class 2


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

MDR Year MDR Reports MDR Events
2018 9 9
2019 10 10
2020 7 7
2021 23 23
2022 11 11
2023 8 8

Device Problems MDRs with this Device Problem Events in those MDRs
False Negative Result 17 17
Low Test Results 14 14
Incorrect, Inadequate or Imprecise Result or Readings 9 9
Unable to Obtain Readings 8 8
High Test Results 7 7
Component Missing 4 4
False Positive Result 4 4
Appropriate Term/Code Not Available 4 4
Non Reproducible Results 4 4
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 41 41
No Consequences Or Impact To Patient 17 17
No Known Impact Or Consequence To Patient 7 7
No Patient Involvement 3 3

Recalls
Manufacturer Recall Class Date Posted
1 Bio-Rad Laboratories, Inc. II Dec-06-2022
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