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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device preservative, cytological
Product CodeLEA
Regulation Number 864.4010
Device Class 1

MDR Year MDR Reports MDR Events
2016 1 1
2019 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
False Negative Result 1 1
Environmental Compatibility Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Menstrual Irregularities 1 1
Patient Problem/Medical Problem 1 1
Cancer 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Leica Biosystems Richmond Inc. III Mar-29-2012
2 Richard-Allan Scientific Company II May-21-2015
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