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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
ABBOTT LABORATORIES
  SUBSTANTIALLY EQUIVALENT 1
BECKMAN COULTER, INC.
  SUBSTANTIALLY EQUIVALENT 1
DIASORIN INC.
  SUBSTANTIALLY EQUIVALENT 1
DIAZYME LABORATORIES
  SUBSTANTIALLY EQUIVALENT 1
ROCHE DIAGNOSTICS
  SUBSTANTIALLY EQUIVALENT 2
ROCHE DIAGNOSTICS CORP.
  SUBSTANTIALLY EQUIVALENT 1
SIEMENS HEALTHCARE DIAGNOSTICS INC.
  SUBSTANTIALLY EQUIVALENT 1
TOSOH BIOSCIENCE, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 4 4
2015 1 1
2016 4 4
2017 6 6
2018 2 2
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 19 19
Low Test Results 13 13
Non Reproducible Results 10 10
Incorrect, Inadequate or Imprecise Result or Readings 7 7
Adverse Event Without Identified Device or Use Problem 5 5
High Readings 4 4
Incorrect Measurement 4 4
No Apparent Adverse Event 2 2
Failure to Calibrate 2 2
Failure to Recalibrate 2 2
Incorrect Or Inadequate Test Results 2 2
Output Problem 1 1
Leak/Splash 1 1
Off-Label Use 1 1
False Negative Result 1 1
Device Ingredient or Reagent 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 10 10
No Known Impact Or Consequence To Patient 9 9
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Chemical Exposure 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 Abbott Laboratories II Apr-15-2009
2 Baxter Healthcare Corp. II Apr-29-2010
3 Beckman Coulter Inc. II Oct-10-2012
4 Ortho Clinical Diagnostics Inc II Oct-03-2018
5 Siemens Healthcare Diagnostics II Dec-24-2013
6 Siemens Healthcare Diagnostics, Inc II Jan-21-2020
7 Siemens Healthcare Diagnostics, Inc II Sep-04-2015
8 Siemens Healthcare Diagnostics, Inc II May-07-2014
9 Siemens Healthcare Diagnostics, Inc II Sep-10-2013
10 Siemens Healthcare Diagnostics, Inc II Dec-11-2012
11 Siemens Healthcare Diagnostics, Inc. II Feb-21-2023
12 Siemens Healthcare Diagnostics, Inc. II May-04-2018
13 Tosoh Bioscience Inc II Dec-22-2018
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