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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, rubella
Regulation Description Rubella virus serological reagents.
Product CodeLFX
Regulation Number 866.3510
Device Class 2


Premarket Reviews
ManufacturerDecision
ABBOTT LABORATORIES
  SUBSTANTIALLY EQUIVALENT 1
BECKMAN COULTER, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2021 13 13
2022 13 13
2023 7 7
2024 13 13
2025 12 12
2026 5 5

Device Problems MDRs with this Device Problem Events in those MDRs
High Test Results 24 24
False Positive Result 17 17
False Negative Result 13 13
Low Test Results 8 8
Non Reproducible Results 6 6
Incorrect, Inadequate or Imprecise Result or Readings 2 2
Incorrect Measurement 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 57 57
No Consequences Or Impact To Patient 6 6

Recalls
Manufacturer Recall Class Date Posted
1 bioMerieux, Inc. II Dec-28-2021
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