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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 13 13

Device Problems MDRs with this Device Problem Events in those MDRs
False Negative Result 28 28
False Positive Result 25 25
Low Test Results 13 13
High Test Results 12 12
Unable to Obtain Readings 8 8
Incorrect, Inadequate or Imprecise Result or 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 82 82
No Consequences Or Impact To Patient 12 12
No Patient Involvement 3 3
No Known Impact Or Consequence To Patient 3 3

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