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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

Device Problems MDRs with this Device Problem Events in those MDRs
High Test Results 22 22
False Positive Result 15 15
False Negative Result 13 13
Low Test Results 8 8
Non Reproducible Results 4 4
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 52 52
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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