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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 272 272

Device Problems MDRs with this Device Problem Events in those MDRs
False Positive Result 208 208
No Apparent Adverse Event 77 77
Improper or Incorrect Procedure or Method 9 9
Material Fragmentation 7 7
False Negative Result 5 5
Corroded 5 5
Use of Device Problem 4 4
Failure to Power Up 3 3
High Test Results 3 3
Crack 2 2
Break 1 1
Incorrect, Inadequate or Imprecise Result or Readings 1 1
Battery Problem 1 1
Insufficient Device Problem Information 1 1
Incorrect Measurement 1 1
Low Readings 1 1
Power Problem 1 1
Nonstandard Device 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 338 338
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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