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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
Product CodeDOF
Regulation Number 862.3550
Device Class 2

MDR Year MDR Reports MDR Events
2019 63 63
2020 2 2
2021 98 98
2022 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Nonstandard Device 97 97
Incorrect, Inadequate or Imprecise Result or Readings 28 28
Low Test Results 16 16
Electrical /Electronic Property Problem 9 9
Battery Problem 8 8
Failure to Run on Battery 6 6
False Negative Result 4 4
Corroded 4 4
Degraded 4 4
Electrical Overstress 4 4
Material Integrity Problem 4 4
Temperature Problem 3 3
Overheating of Device 3 3
Failure to Sense 2 2
Device Sensing Problem 2 2
Calibration Problem 1 1
Noise, Audible 1 1
Power Problem 1 1
Failure to Power Up 1 1
Imprecision 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Insufficient Information 74 74
No Known Impact Or Consequence To Patient 40 40
No Clinical Signs, Symptoms or Conditions 23 23
No Consequences Or Impact To Patient 17 17
Test Result 9 9
Patient Problem/Medical Problem 5 5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Burn(s) 1 1
Superficial (First Degree) Burn 1 1

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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