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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device susceptibility test cards, antimicrobial
Product CodeLTW
Regulation Number 866.1640
Device Class 2

MDR Year MDR Reports MDR Events
2014 3 3
2016 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect, Inadequate or Imprecise Result or Readings 4 4
False Negative Result 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 4 4

Recalls
Manufacturer Recall Class Date Posted
1 Biomerieux Inc II Jan-04-2023
2 Biomerieux Inc I May-11-2016
3 Biomerieux Inc II May-12-2015
4 Biomerieux Inc III Apr-08-2015
5 Biomerieux Inc II Aug-06-2013
6 Biomerieux Inc II Mar-27-2013
7 Biomerieux Inc II Mar-25-2013
8 Biomerieux Inc II Jul-09-2011
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