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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
2020
11
11
2021
28
28
2022
24
24
2023
28
28
2024
33
33
2025
28
28
Device Problems
MDRs with this Device Problem
Events in those MDRs
High Test Results
75
75
Low Test Results
39
39
Non Reproducible Results
25
25
Incorrect, Inadequate or Imprecise Result or Readings
20
20
Appropriate Term/Code Not Available
5
5
Patient Device Interaction Problem
4
4
Adverse Event Without Identified Device or Use Problem
4
4
Low Readings
4
4
Use of Device Problem
3
3
Device Handling Problem
3
3
Incorrect Measurement
3
3
Output Problem
2
2
Erratic Results
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
1
False Positive Result
1
1
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
116
116
Insufficient Information
13
13
No Known Impact Or Consequence To Patient
6
6
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
4
4
Laceration(s)
4
4
Head Injury
2
2
Bone Fracture(s)
2
2
Abrasion
2
2
No Consequences Or Impact To Patient
2
2
No Code Available
1
1
Test Result
1
1
Crushing Injury
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
Beckman Coulter, Inc.
II
Jul-11-2025
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