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TPLC
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show TPLC since
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Device
lead, atomic absorption
Product Code
DOF
Regulation Number
862.3550
Device Class
2
MDR Year
MDR Reports
MDR Events
2018
40
40
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
29
29
Low Test Results
16
16
Failure to Sense
14
14
Device Sensing Problem
14
14
False Negative Result
14
14
Battery Problem
9
9
Electrical /Electronic Property Problem
9
9
Complete Loss of Power
9
9
Failure to Run on Battery
6
6
Temperature Problem
5
5
Device Handling Problem
5
5
Material Integrity Problem
4
4
Corroded
4
4
Degraded
4
4
Electrical Overstress
4
4
Failure to Power Up
3
3
Overheating of Device
3
3
Imprecision
2
2
Calibration Problem
2
2
Noise, Audible
2
2
Power Problem
1
1
Product Quality Problem
1
1
Electrical Shorting
1
1
Manufacturing, Packaging or Shipping Problem
1
1
Smoking
1
1
Use of Device Problem
1
1
Improper or Incorrect Procedure or Method
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Insufficient Information
74
74
No Known Impact Or Consequence To Patient
62
62
No Clinical Signs, Symptoms or Conditions
23
23
No Consequences Or Impact To Patient
20
20
No Patient Involvement
9
9
Test Result
9
9
Patient Problem/Medical Problem
6
6
No Information
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.
I
Jul-01-2021
2
Magellan Diagnostics, Inc.
II
Oct-26-2018
3
Magellan Diagnostics, Inc.
II
Apr-03-2018
4
Mckesson Medical-Surgical Inc. Corporate Office
II
Aug-26-2022
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