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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device clinical sample concentrator
Regulation Description Clinical sample concentrator.
Product CodeJJH
Regulation Number 862.2310
Device Class 1

Device Problems
Contamination During Use 9
Device Displays Incorrect Message 5
Leak / Splash 5
Device Contamination with Body Fluid 4
Fluid Leak 4
Device Operates Differently Than Expected 3
Incorrect, Inadequate or Imprecise Result or Readings 3
Contamination / decontamination Problem 3
Incorrect Or Inadequate Test Results 3
Circuit Failure 3
Use of Device Problem 2
Computer Operating System Problem 1
Device Dislodged or Dislocated 1
Flare or Flash 1
Device Handling Problem 1
Missing Test Results 1
Mechanical Problem 1
Smoking 1
Device Ingredient or Reagent Problem 1
Detachment Of Device Component 1
False Positive Result 1
False Negative Result 1
Fire 1
Charred 1
Overheating of Device 1
Sparking 1
Device Markings / Labelling Problem 1
Human-Device Interface Problem 1
Pumping Problem 1
Total Device Problems 62

Recalls
Manufacturer Recall Class Date Posted
1 Abbott Molecular II Jan-09-2015
2 Becton Dickinson & Co. II Aug-22-2019
3 Merck Millipore Ltd. II Nov-20-2018
4 QIAGEN II Aug-02-2018
5 Qiagen Sciences LLC II Aug-21-2019
6 Qiagen Sciences LLC I Aug-01-2019
7 Qiagen Sciences LLC II Nov-03-2018
8 Roche Molecular Systems, Inc. II Jul-10-2020
9 Roche Molecular Systems, Inc. II May-30-2018
10 Roche Molecular Systems, Inc. II Apr-27-2016
11 bioMerieux, Inc. II Sep-12-2017

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