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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device radioassay, vitamin b12
Product CodeCDD
Regulation Number 862.1810
Device Class 2


Premarket Reviews
ManufacturerDecision
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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