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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device reagents, zika virus nucleic acid
Definition Nucleic acid-based in vitro diagnostic devices for the detection of Zika virus and diagnosis of Zika virus infection in human clinical specimens.
Product CodePOA
Device Class Not Classified

MDR Year MDR Reports MDR Events
2016 2 2
2017 14 14

Device Problems MDRs with this Device Problem Events in those MDRs
False Positive Result 13 13
Incorrect Or Inadequate Test Results 3 3

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Information 8 8
No Known Impact Or Consequence To Patient 5 5
No Consequences Or Impact To Patient 2 2
Misdiagnosis 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Roche Molecular Systems, Inc. II Dec-13-2016
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