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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
2021 98 99
2022 1 1
2025 55 55
2026 224 224

Device Problems MDRs with this Device Problem Events in those MDRs
False Positive Result 162 162
No Apparent Adverse Event 76 76
Improper or Incorrect Procedure or Method 9 9
Material Fragmentation 7 7
Corroded 5 5
False Negative Result 5 5
Use of Device Problem 4 4
High Test Results 3 3
Failure to Power Up 2 2
Crack 2 2
Insufficient Device Problem Information 1 1
Break 1 1
Low Readings 1 1
Battery Problem 1 1
Incorrect, Inadequate or Imprecise Result or Readings 1 1
Nonstandard Device 1 1
Incorrect Measurement 1 1
Power Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 290 290
Insufficient Information 85 86
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available 2 2
Laceration(s) 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Magellan Diagnostics, Inc. II Apr-17-2026
2 Magellan Diagnostics, Inc. II Nov-21-2025
3 Magellan Diagnostics, Inc. II Nov-03-2023
4 Magellan Diagnostics, Inc. I Jul-01-2021
5 Mckesson Medical-Surgical Inc. Corporate Office II Aug-26-2022
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