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TPLC
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show TPLC since
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2024
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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
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
19
19
Device Problems
MDRs with this Device Problem
Events in those MDRs
High Test Results
68
68
Low Test Results
38
38
Non Reproducible Results
18
18
Incorrect, Inadequate or Imprecise Result or Readings
17
17
Adverse Event Without Identified Device or Use Problem
14
14
Incorrect Or Inadequate Test Results
8
8
No Apparent Adverse Event
4
4
Patient Device Interaction Problem
4
4
Device Handling Problem
4
4
Incorrect Measurement
3
3
Appropriate Term/Code Not Available
3
3
Use of Device Problem
3
3
Imprecision
2
2
Low Readings
2
2
Improper or Incorrect Procedure or Method
2
2
Sharp Edges
1
1
Device Contamination with Chemical or Other Material
1
1
Fluid/Blood Leak
1
1
Mechanical Problem
1
1
Erratic Results
1
1
Patient Data Problem
1
1
Material Integrity Problem
1
1
Unsealed Device Packaging
1
1
Connection Problem
1
1
False Positive Result
1
1
Crack
1
1
Data Problem
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
81
81
No Known Impact Or Consequence To Patient
41
41
No Consequences Or Impact To Patient
19
19
Insufficient Information
8
8
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
4
4
No Code Available
3
3
Abrasion
3
3
Injury
3
3
Test Result
2
2
Head Injury
2
2
Bone Fracture(s)
2
2
Laceration(s)
2
2
Concussion
1
1
Pain
1
1
Muscle/Tendon Damage
1
1
Eye Injury
1
1
Bruise/Contusion
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Beckman Coulter Biomedical GmbH
II
Sep-05-2024
2
Beckman Coulter Inc.
II
Oct-14-2021
3
Ortho-Clinical Diagnostics
II
Nov-06-2018
4
Siemens Healthcare Diagnostics, Inc.
II
May-04-2018
5
Siemens Healthcare Diagnostics, Inc.
II
Jun-27-2012
6
Tosoh Bioscience Inc
II
Dec-22-2018
7
Tosoh Smd Inc
III
Dec-26-2019
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