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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 123 123

Device Problems MDRs with this Device Problem Events in those MDRs
Nonstandard Device 97 98
No Apparent Adverse Event 76 76
False Positive Result 68 68
Improper or Incorrect Procedure or Method 9 9
Material Fragmentation 7 7
Use of Device Problem 4 4
False Negative Result 3 3
Crack 2 2
Incorrect, Inadequate or Imprecise Result or Readings 2 2
Failure to Power Up 2 2
Break 1 1
Output Problem 1 1
Battery Problem 1 1
Incorrect Measurement 1 1
Low Readings 1 1
Power Problem 1 1
Corroded 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 198 198
Insufficient Information 76 77
Appropriate Clinical Signs, Symptoms, 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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