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TPLC
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show TPLC since
2009
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2024
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Device
acid, folic, radioimmunoassay
Product Code
CGN
Regulation Number
862.1295
Device Class
2
Premarket Reviews
Manufacturer
Decision
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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