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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
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
Electrical Overstress
4
4
Material Integrity Problem
4
4
Degraded
4
4
Corroded
4
4
Overheating of Device
3
3
Temperature Problem
3
3
Failure to Sense
2
2
Device Sensing Problem
2
2
Imprecision
1
1
Failure to Power Up
1
1
Calibration Problem
1
1
Power Problem
1
1
Noise, Audible
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
Superficial (First Degree) Burn
1
1
Burn(s)
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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