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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

MDR Year MDR Reports MDR Events
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 Negative Result 30 30
False Positive Result 29 29
Low Test Results 16 16
High Test Results 12 12
Incorrect, Inadequate or Imprecise Result or Readings 8 8
Unable to Obtain Readings 8 8
Non Reproducible Results 5 5
Component Missing 4 4
Appropriate Term/Code Not Available 4 4
Device Displays Incorrect Message 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 91 91
No Consequences Or Impact To Patient 12 12
No Known Impact Or Consequence To Patient 3 3
No Patient Involvement 3 3

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