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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device acid, folic, radioimmunoassay
Regulation Description Folic acid test system.
Product CodeCGN
Regulation Number 862.1295
Device Class 2


Premarket Reviews
ManufacturerDecision
BECKMAN COULTER, INC.
  SUBSTANTIALLY EQUIVALENT 1
ROCHE DIAGNOSTICS
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2021 3 3
2022 13 15
2023 8 8
2024 19 19
2025 9 9
2026 4 4

Device Problems MDRs with this Device Problem Events in those MDRs
Non Reproducible Results 23 25
Low Test Results 22 23
High Test Results 19 20
Incorrect, Inadequate or Imprecise Result or Readings 9 9
Failure to Recalibrate 4 5
High Readings 4 5
Incorrect Measurement 3 3
Output Problem 2 2
Failure to Calibrate 2 3
Leak/Splash 1 1
Off-Label Use 1 1
Product Quality Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 55 57
Conjunctivitis 1 1
Chemical Exposure 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Ortho-Clinical Diagnostics, Inc. II Aug-12-2024
2 Siemens Healthcare Diagnostics, Inc. II Feb-21-2023
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