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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
Regulation Description Cytomegalovirus serological reagents.
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
2020 7 7
2021 23 23
2022 11 11
2023 36 36
2024 34 34
2025 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
False Positive Result 35 35
False Negative Result 34 34
Low Test Results 16 16
High Test Results 13 13
Unable to Obtain Readings 8 8
Non Reproducible Results 5 5
Component Missing 4 4
Appropriate Term/Code Not Available 4 4
Incorrect, Inadequate or Imprecise Result or Readings 3 3
Device Displays Incorrect Message 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 105 105
No Consequences Or Impact To Patient 5 5
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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