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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device alcohol dehydrogenase, specific reagent for ethanol enzyme method
Regulation Description Alcohol test system.
Product CodeDIC
Regulation Number 862.3040
Device Class 2

MDR Year MDR Reports MDR Events
2020 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect, Inadequate or Imprecise Result or Readings 1 1

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

Recalls
Manufacturer Recall Class Date Posted
1 Siemens Healthcare Diagnostics, Inc. II Feb-27-2020
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