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TPLC
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show TPLC since
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Device
radioassay, vitamin b12
Product Code
CDD
Regulation Number
862.1810
Device Class
2
Premarket Reviews
Manufacturer
Decision
ABBOTT LABORATORIES
SUBSTANTIALLY EQUIVALENT
2
ANTICANCER INC
SUBSTANTIALLY EQUIVALENT
1
AXIS-SHIELD DIAGNOSTICS LIMITED
SUBSTANTIALLY EQUIVALENT
1
AXIS-SHIELD DIAGNOSTICS LTD.
SUBSTANTIALLY EQUIVALENT
1
AXIS-SHIELD DIAGNOSTICS, LTD.
SUBSTANTIALLY EQUIVALENT
2
BECKMAN COULTER BIOMEDICAL GMBH
SUBSTANTIALLY EQUIVALENT
1
BECKMAN COULTER, INC.
SUBSTANTIALLY EQUIVALENT
4
DIASORIN INC.
SUBSTANTIALLY EQUIVALENT
1
DIAZYME LABORATORIES
SUBSTANTIALLY EQUIVALENT
1
ROCHE DIAGNOSTICS
SUBSTANTIALLY EQUIVALENT
1
SIEMENS HEALTHCARE DIAGNOSTICS
SUBSTANTIALLY EQUIVALENT
2
SIEMENS HEALTHCARE DIAGNOSTICS INC.
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2014
12
12
2015
4
4
2016
6
6
2017
9
9
2018
15
15
2019
14
14
2020
11
11
2021
28
28
2022
24
24
2023
28
28
2024
7
7
Device Problems
MDRs with this Device Problem
Events in those MDRs
High Test Results
65
65
Low Test Results
34
34
Incorrect, Inadequate or Imprecise Result or Readings
15
15
Non Reproducible Results
15
15
Adverse Event Without Identified Device or Use Problem
14
14
Incorrect Or Inadequate Test Results
8
8
Device Handling Problem
4
4
No Apparent Adverse Event
4
4
Appropriate Term/Code Not Available
3
3
Use of Device Problem
3
3
Patient Device Interaction Problem
3
3
Improper or Incorrect Procedure or Method
2
2
Imprecision
2
2
Incorrect Measurement
2
2
Low Readings
2
2
Connection Problem
1
1
Device Contamination with Chemical or Other Material
1
1
Material Integrity Problem
1
1
Data Problem
1
1
Patient Data Problem
1
1
Mechanical Problem
1
1
Unsealed Device Packaging
1
1
Crack
1
1
False Positive Result
1
1
Fluid/Blood Leak
1
1
Sharp Edges
1
1
Erratic Results
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
71
71
No Known Impact Or Consequence To Patient
41
41
No Consequences Or Impact To Patient
19
19
Insufficient Information
7
7
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
4
4
No Code Available
3
3
Injury
3
3
Abrasion
3
3
Bone Fracture(s)
2
2
Head Injury
2
2
Laceration(s)
2
2
Test Result
2
2
Muscle/Tendon Damage
1
1
Concussion
1
1
Bruise/Contusion
1
1
Eye Injury
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Beckman Coulter Inc.
II
Oct-14-2021
2
Ortho-Clinical Diagnostics
II
Nov-06-2018
3
Siemens Healthcare Diagnostics, Inc.
II
May-04-2018
4
Siemens Healthcare Diagnostics, Inc.
II
Jun-27-2012
5
Tosoh Bioscience Inc
II
Dec-22-2018
6
Tosoh Smd Inc
III
Dec-26-2019
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