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TPLC
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Device
radioassay, vitamin b12
Regulation Description
Vitamin B12 test system.
Product Code
CDD
Regulation Number
862.1810
Device Class
2
Premarket Reviews
Manufacturer
Decision
AXIS-SHIELD DIAGNOSTICS, LTD.
SUBSTANTIALLY EQUIVALENT
1
BECKMAN COULTER, INC.
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2021
28
28
2022
24
24
2023
27
28
2024
33
33
2025
45
45
2026
4
4
Device Problems
MDRs with this Device Problem
Events in those MDRs
High Test Results
83
83
Low Test Results
40
41
Non Reproducible Results
28
29
Incorrect, Inadequate or Imprecise Result or Readings
20
21
Adverse Event Without Identified Device or Use Problem
5
5
Appropriate Term/Code Not Available
5
5
Patient Device Interaction Problem
4
4
Device Handling Problem
4
4
Low Readings
4
4
Erratic Results
3
3
Use of Device Problem
3
3
Output Problem
2
2
Incorrect Measurement
2
2
False Positive Result
2
2
Chemical Problem
1
1
Device Ingredient or Reagent Problem
1
1
Mechanical Problem
1
1
Crack
1
1
Unsealed Device Packaging
1
1
Material Integrity Problem
1
1
Imprecision
1
1
Sharp Edges
1
1
Calibration Problem
1
1
No Apparent Adverse Event
1
2
Improper or Incorrect Procedure or Method
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
131
132
Insufficient Information
13
13
Laceration(s)
5
5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
4
4
Head Injury
2
2
Bone Fracture(s)
2
2
Abrasion
2
2
Crushing Injury
2
2
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
Beckman Coulter, Inc.
II
Jul-11-2025
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