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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
  1.  K223590  Access Folate Assay
DIASORIN INC.
  SUBSTANTIALLY EQUIVALENT 1
ROCHE DIAGNOSTICS
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 1 1
2020 5 5
2021 3 3
2022 13 13
2023 8 8
2024 19 19
2025 9 9

Device Problems MDRs with this Device Problem Events in those MDRs
Non Reproducible Results 22 22
Low Test Results 20 20
High Test Results 19 19
Incorrect, Inadequate or Imprecise Result or Readings 9 9
High Readings 5 5
Incorrect Measurement 5 5
Failure to Recalibrate 3 3
Output Problem 2 2
No Apparent Adverse Event 2 2
Failure to Calibrate 2 2
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 51 51
No Consequences Or Impact To Patient 3 3
No Known Impact Or Consequence To Patient 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Chemical Exposure 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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