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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device radioimmunoassay, estriol
Product CodeCGI
Regulation Number 862.1265
Device Class 1

MDR Year MDR Reports MDR Events
2020 1 1
2022 1 1
2023 7 7

Device Problems MDRs with this Device Problem Events in those MDRs
Low Test Results 8 8
Device Contamination with Chemical or Other Material 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 8 8
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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