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TPLC
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Device
radioassay, vitamin b12
Product Code
CDD
Regulation Number
862.1810
Device Class
2
Premarket Reviews
Manufacturer
Decision
AXIS-SHIELD DIAGNOSTICS, LTD
SUBSTANTIALLY EQUIVALENT
1
BECKMAN COULTER BIOMEDICAL GMBH
SUBSTANTIALLY EQUIVALENT
1
BECKMAN COULTER, INC.
SUBSTANTIALLY EQUIVALENT
1
DIASORIN INC.
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
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
57
57
Low Test Results
28
28
Non Reproducible Results
17
17
Incorrect, Inadequate or Imprecise Result or Readings
14
14
Adverse Event Without Identified Device or Use Problem
6
6
Device Handling Problem
4
4
Patient Device Interaction Problem
4
4
Use of Device Problem
3
3
Incorrect Measurement
3
3
Appropriate Term/Code Not Available
3
3
Low Readings
2
2
No Apparent Adverse Event
2
2
Crack
1
1
Material Integrity Problem
1
1
Unsealed Device Packaging
1
1
Imprecision
1
1
Sharp Edges
1
1
Erratic Results
1
1
False Positive Result
1
1
Improper or Incorrect Procedure or Method
1
1
Fluid/Blood Leak
1
1
Mechanical 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
11
11
Insufficient Information
8
8
No Consequences Or Impact To Patient
6
6
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
4
4
Abrasion
3
3
Injury
3
3
Head Injury
2
2
Bone Fracture(s)
2
2
Laceration(s)
2
2
No Code Available
1
1
Test Result
1
1
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
Tosoh Smd Inc
III
Dec-26-2019
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