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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 lipase-esterase, enzymatic, photometric, lipase
Regulation Description Lipase test system.
Product CodeCHI
Regulation Number 862.1465
Device Class 1

Device Problems
High Test Results 8
Adverse Event Without Identified Device or Use Problem 6
Low Test Results 3
Mechanical Problem 3
Insufficient Information 2
Probe 1
Non Reproducible Results 1
Device Ingredient or Reagent Problem 1
Total Device Problems 25

Recalls
Manufacturer Recall Class Date Posted
1 Abbott Laboratories, Inc II Oct-28-2014
2 Medica Corporation II May-07-2019
3 Medica Corporation II Mar-21-2018
4 Siemens Healthcare Diagnostics, Inc. II Nov-14-2018
5 Siemens Healthcare Diagnostics, Inc. II May-10-2018
6 Siemens Healthcare Diagnostics, Inc. II Apr-20-2015

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