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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
DIASORIN INC.
  SUBSTANTIALLY EQUIVALENT 1
ROCHE DIAGNOSTICS
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 5 5
2021 3 3
2022 13 13
2023 9 9
2024 20 20

Device Problems MDRs with this Device Problem Events in those MDRs
High Test Results 19 19
Low Test Results 18 18
Non Reproducible Results 15 15
Incorrect, Inadequate or Imprecise Result or Readings 7 7
Incorrect Measurement 6 6
High Readings 5 5
Failure to Recalibrate 3 3
Output Problem 2 2
Failure to Calibrate 2 2
Leak/Splash 1 1
Off-Label Use 1 1
Product Quality Problem 1 1
No Apparent Adverse Event 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 44 44
No Consequences Or Impact To Patient 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Chemical Exposure 1 1
No Known Impact Or Consequence To Patient 1 1
Conjunctivitis 1 1
Hyperglycemia 1 1
Hypoglycemia 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Ortho-Clinical Diagnostics, Inc. II Aug-12-2024
2 Siemens Healthcare Diagnostics, Inc II Jan-21-2020
3 Siemens Healthcare Diagnostics, Inc. II Feb-21-2023
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