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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
SIEMENS HEALTHCARE DIAGNOSTICS INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2018 2 2
2019 1 1
2020 5 5
2021 3 3
2022 13 13
2023 4 4

Device Problems MDRs with this Device Problem Events in those MDRs
High Test Results 13 13
Low Test Results 6 6
Non Reproducible Results 6 6
Incorrect, Inadequate or Imprecise Result or Readings 5 5
Incorrect Measurement 4 4
High Readings 4 4
Failure to Calibrate 2 2
Failure to Recalibrate 2 2
No Apparent Adverse Event 2 2
Off-Label Use 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Output Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 19 19
No Known Impact Or Consequence To Patient 4 4
No Consequences Or Impact To Patient 3 3
Chemical Exposure 1 1
Conjunctivitis 1 1
Hyperglycemia 1 1
Hypoglycemia 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 Oct-03-2018
2 Siemens Healthcare Diagnostics, Inc II Jan-21-2020
3 Siemens Healthcare Diagnostics, Inc. II Feb-21-2023
4 Siemens Healthcare Diagnostics, Inc. II May-04-2018
5 Tosoh Bioscience Inc II Dec-22-2018
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