• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

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
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
-
-