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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device radioimmunoassay, estriol
Regulation Description Estriol test system.
Product CodeCGI
Regulation Number 862.1265
Device Class 1

MDR Year MDR Reports MDR Events
2015 1 1
2017 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 2 2
High Test Results 1 1

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

Recalls
Manufacturer Recall Class Date Posted
1 Beckman Coulter Inc. II Sep-24-2020
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