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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Super Search Devices@FDA
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New Search show TPLC since Back to Search Results
Device radioassay, vitamin b12
Regulation Description Vitamin B12 test system.
Product CodeCDD
Regulation Number 862.1810
Device Class 2


Premarket Reviews
ManufacturerDecision
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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