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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
2021 23 23
2022 11 11
2023 36 36
2024 34 34
2025 54 56
2026 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
False Positive Result 56 56
False Negative Result 52 53
Low Test Results 28 28
High Test Results 18 18
Non Reproducible Results 8 8
Unable to Obtain Readings 8 8
Component Missing 4 4
Appropriate Term/Code Not Available 4 4
Incorrect, Inadequate or Imprecise Result or Readings 1 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 159 161
No Consequences Or Impact To Patient 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Bio-Rad Laboratories, Inc. II Dec-06-2022
2 GET TESTED INTERNATIONAL AB II Dec-01-2025
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