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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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New Search show TPLC since Back to Search Results
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
DIASORIN INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2017 9 9
2018 15 15
2019 14 14
2020 11 11
2021 28 28
2022 21 21

Device Problems MDRs with this Device Problem Events in those MDRs
High Test Results 36 36
Low Test Results 22 22
Adverse Event Without Identified Device or Use Problem 12 12
Incorrect, Inadequate or Imprecise Result or Readings 7 7
Non Reproducible Results 5 5
Device Handling Problem 4 4
Patient Device Interaction Problem 3 3
Use of Device Problem 3 3
No Apparent Adverse Event 3 3
Low Readings 2 2
Improper or Incorrect Procedure or Method 1 1
False Positive Result 1 1
Unsealed Device Packaging 1 1
Appropriate Term/Code Not Available 1 1
Erratic Results 1 1
Incorrect Or Inadequate Test Results 1 1
Fluid/Blood Leak 1 1
Incorrect Measurement 1 1
Sharp Edges 1 1
Connection Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 38 38
No Known Impact Or Consequence To Patient 25 25
No Consequences Or Impact To Patient 14 14
Insufficient Information 6 6
Injury 3 3
No Code Available 3 3
Bone Fracture(s) 2 2
Abrasion 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Head Injury 2 2
Laceration(s) 1 1
Test Result 1 1
Eye Injury 1 1
Concussion 1 1
Muscle/Tendon Damage 1 1
Bruise/Contusion 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Beckman Coulter Inc. II Oct-14-2021
2 Ortho-Clinical Diagnostics II Nov-06-2018
3 Siemens Healthcare Diagnostics, Inc. II May-04-2018
4 Tosoh Bioscience Inc II Dec-22-2018
5 Tosoh Smd Inc III Dec-26-2019
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