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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device lead, atomic absorption
Regulation Description Lead test system.
Product CodeDOF
Regulation Number 862.3550
Device Class 2

MDR Year MDR Reports MDR Events
2020 2 2
2021 98 98
2022 1 1
2025 16 16

Device Problems MDRs with this Device Problem Events in those MDRs
Nonstandard Device 97 97
Material Fragmentation 4 4
No Apparent Adverse Event 3 3
Crack 2 2
Electrical Overstress 2 2
Incorrect, Inadequate or Imprecise Result or Readings 2 2
Failure to Power Up 2 2
Electrical /Electronic Property Problem 2 2
Improper or Incorrect Procedure or Method 2 2
False Negative Result 1 1
Power Problem 1 1
False Positive Result 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Insufficient Information 75 75
No Clinical Signs, Symptoms or Conditions 38 38
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
No Consequences Or Impact To Patient 2 2

Recalls
Manufacturer Recall Class Date Posted
1 Magellan Diagnostics, Inc. II Nov-03-2023
2 Magellan Diagnostics, Inc. I Jul-01-2021
3 Mckesson Medical-Surgical Inc. Corporate Office II Aug-26-2022
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