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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
DIASORIN INC.
  SUBSTANTIALLY EQUIVALENT 1
SIEMENS HEALTHCARE DIAGNOSTICS INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2017 6 6
2018 2 2
2019 1 1
2020 5 5
2021 3 3
2022 6 6

Device Problems MDRs with this Device Problem Events in those MDRs
Low Test Results 5 5
High Test Results 4 4
Incorrect Measurement 4 4
Adverse Event Without Identified Device or Use Problem 4 4
Non Reproducible Results 4 4
High Readings 3 3
Incorrect, Inadequate or Imprecise Resultor Readings 2 2
No Apparent Adverse Event 2 2
Failure to Calibrate 1 1
Incorrect Or Inadequate Test Results 1 1
Off-Label Use 1 1
Failure to Recalibrate 1 1
Device Ingredient or Reagent Problem 1 1
False Negative Result 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 8 8
No Known Impact Or Consequence To Patient 6 6
No Consequences Or Impact To Patient 4 4
Chemical Exposure 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Conjunctivitis 1 1
Death, Intrauterine Fetal 1 1
Hyperglycemia 1 1
Hypoglycemia 1 1
Miscarriage 1 1
Venipuncture 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Ortho Clinical Diagnostics Inc II Oct-03-2018
2 Siemens Healthcare Diagnostics, Inc II Jan-21-2020
3 Siemens Healthcare Diagnostics, Inc. II May-04-2018
4 Tosoh Bioscience Inc II Dec-22-2018
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