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TPLC
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Device
radioimmunoassay, androstenedione
Product Code
CIZ
Regulation Number
862.1075
Device Class
1
MDR Year
MDR Reports
MDR Events
2014
114
114
2016
1
1
2017
1
1
Device Problems
MDRs with this Device Problem
Events in those MDRs
High Test Results
77
77
Nonstandard Device
57
57
Incorrect Or Inadequate Test Results
16
16
Incorrect, Inadequate or Imprecise Result or Readings
7
7
High Readings
4
4
False Positive Result
3
3
Adverse Event Without Identified Device or Use Problem
2
2
Low Test Results
2
2
Device Operates Differently Than Expected
2
2
False Negative Result
1
1
Calibration Problem
1
1
Inadequate Instructions for Healthcare Professional
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Known Impact Or Consequence To Patient
91
91
No Consequences Or Impact To Patient
23
23
Death
1
1
No Information
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Siemens Healthcare Diagnostics
II
Apr-30-2014
2
Siemens Healthcare Diagnostics Inc.
II
Jul-15-2014
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