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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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New Search show TPLC since Back to Search Results
Device colorimetry, acetaminophen
Regulation Description Acetaminophen test system.
Product CodeLDP
Regulation Number 862.3030
Device Class 2

Device Problems
Incorrect, Inadequate or Imprecise Result or Readings 5
High Test Results 5
High Readings 5
Low Test Results 1
Total Device Problems 16

Recalls
Manufacturer Recall Class Date Posted
1 Beckman Coulter Inc. II Sep-12-2017
2 Roche Diagnostics Corporation II Apr-25-2018
3 Sekisui Diagnostics P.E.I. Inc. II Mar-14-2016
4 Siemens Healthcare Diagnostics, Inc. II Aug-19-2015

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