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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device analyzer, chemistry, micro, for clinical use
Product CodeJJF
Regulation Number 862.2170
Device Class 1

MDR Year MDR Reports MDR Events
2022 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
False Positive Result 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Insufficient Information 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Vital Scientific N.V. II Nov-22-2019
2 Vital Scientific N.V. II Oct-16-2019
3 Vital Scientific N.V. II Oct-04-2019
4 Vital Scientific N.V. II Sep-23-2019
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