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TPLC
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show TPLC since
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Device
nitrophenylphosphate, alkaline phosphatase or isoenzymes
Product Code
CJE
Regulation Number
862.1050
Device Class
2
Premarket Reviews
Manufacturer
Decision
ABBOTT IRELAND DIAGNOSTICS DIVISION
SUBSTANTIALLY EQUIVALENT
1
ABBOTT LABORATORIES DIAGNOSTICS DIVISION
SUBSTANTIALLY EQUIVALENT
1
HORIBA ABX SAS
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2019
1
1
2020
1
1
2021
1
1
2022
6
6
2023
11
11
2024
11
11
Device Problems
MDRs with this Device Problem
Events in those MDRs
Non Reproducible Results
15
15
High Test Results
15
15
Low Test Results
4
4
Material Integrity Problem
2
2
Incorrect, Inadequate or Imprecise Result or Readings
2
2
Chemical Problem
1
1
Incorrect Measurement
1
1
Computer Software Problem
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
29
29
No Consequences Or Impact To Patient
2
2
Recalls
Manufacturer
Recall Class
Date Posted
1
Ortho-Clinical Diagnostics, INc.
II
Sep-21-2023
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