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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device radioimmunoassay, androstenedione
Product CodeCIZ
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
Device Operates Differently Than Expected 2 2
Low Test Results 2 2
Inadequate Instructions for Healthcare Professional 1 1
Calibration Problem 1 1
False Negative Result 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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