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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
Product CodeCGN
Regulation Number 862.1295
Device Class 2


Premarket Reviews
ManufacturerDecision
BECKMAN COULTER, INC.
  SUBSTANTIALLY EQUIVALENT 1
DIASORIN INC.
  SUBSTANTIALLY EQUIVALENT 1

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

Device Problems MDRs with this Device Problem Events in those MDRs
High Test Results 15 15
Low Test Results 10 10
Non Reproducible Results 10 10
Incorrect, Inadequate or Imprecise Result or Readings 6 6
High Readings 4 4
Incorrect Measurement 4 4
Failure to Recalibrate 2 2
Failure to Calibrate 2 2
No Apparent Adverse Event 2 2
Leak/Splash 1 1
Off-Label Use 1 1
Output Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 27 27
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 Siemens Healthcare Diagnostics, Inc II Jan-21-2020
2 Siemens Healthcare Diagnostics, Inc. II Feb-21-2023
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