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U.S. Department of Health and Human Services

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


Premarket Reviews
ManufacturerDecision
BECKMAN COULTER INC.
  SUBSTANTIALLY EQUIVALENT 1
BECKMAN COULTER, INC
  SUBSTANTIALLY EQUIVALENT 2
BECKMAN COULTER, INC.
  SUBSTANTIALLY EQUIVALENT 6
SIEMENS HEALTHCARE DIAGNOSTICS
  SUBSTANTIALLY EQUIVALENT 3
SIEMENS HEALTHCARE DIAGNOSTICS INC.
  SUBSTANTIALLY EQUIVALENT 2
SIEMENS HEALTHCARE DIAGNOSTICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
SIEMENS HELATHCARE DIAGNOSTICS INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 9 9
2015 10 10
2016 1 1
2017 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect Or Inadequate Test Results 12 12
Nonstandard Device 8 8
Device Operates Differently Than Expected 4 4
Adverse Event Without Identified Device or Use Problem 4 4
Appropriate Term/Code Not Available 1 1
Product Quality Problem 1 1
False Negative Result 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 11 11
No Information 6 6
No Patient Involvement 4 4
Not Applicable 2 2

Recalls
Manufacturer Recall Class Date Posted
1 Beckman Coulter Inc. II Aug-02-2018
2 Beckman Coulter Inc. II Dec-30-2015
3 Beckman Coulter Inc. II Oct-07-2015
4 Siemens Healthcare Diagnostics, Inc. II Jun-08-2013
5 Siemens Healthcare Diagnostics, Inc. II May-08-2013
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