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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device manual antimicrobial susceptibility test systems
Product CodeJWY
Regulation Number 866.1640
Device Class 2


Premarket Reviews
ManufacturerDecision
AB BIOMERIEUX
  SUBSTANTIALLY EQUIVALENT 1
BECKMAN COULTER, INC.
  SUBSTANTIALLY EQUIVALENT 4
BIOMERIEUX
  SUBSTANTIALLY EQUIVALENT 1
BIOMÉRIEUX
  SUBSTANTIALLY EQUIVALENT 1
BIOMÉRIEUX S.A.
  SUBSTANTIALLY EQUIVALENT 1
BIOMERIEUX SA
  SUBSTANTIALLY EQUIVALENT 9
BIOMERIEUX, INC
  SUBSTANTIALLY EQUIVALENT 1
BIOMERIEUX, INC.
  SUBSTANTIALLY EQUIVALENT 2
LIOFILCHEM S. R. 1.
  SUBSTANTIALLY EQUIVALENT 1
LIOFILCHEM S. R. L.
  SUBSTANTIALLY EQUIVALENT 22
  1.  K163298  Liofilchem MIC Test Strip (MTS) Ceftazidime 0.016 ...
  2.  K170892  Liofilchem MIC Test Strip (MTS)- Tedizolid 0.002 - ...
  3.  K171906  Liofilchem MIC Test Strip (MTS)- Delafloxacin 0.00 ...
  4.  K172109  Liofilchem MIC Test Strip (MTS), Erythromycin 0.01 ...
  5.  K172542  Liofilchem MIC Test Strip (MTS)- Tedizolid 0.002 - ...
  6.  K173307  Liofilchem MIC Test Strip (MTS), Meropenem/vaborba ...
  7.  K173817  Liofilchem MIC Test Strip (MTS), Ceftazidime-aviba ...
  8.  K180330  Liofilchem MIC Test Strip (MTS)- Linezolid 0.016 - ...
  9.  K180339  Liofilchem MIC Test Strip (MTS), Azithromycin 0.01 ...
  10.  K180886  Liofilchem MIC Test Strip (MTS), Delafloxacin 0.00 ...
  11.  K181708  MTS Plazomicin 0.016-256 µg/mL
  12.  K181889  MTS Penicillin 0.002- 32 µg/mL
  13.  K182557  MTS Eravacycline 0.002 - 32 µg/mL
  14.  K182922  MTS Omadacycline 0.002-32 µg/mL
  15.  K183115  MTS Levofloxacin 0.002 - 32 µg/mL
  16.  K183527  MTS Ciprofloxacin 0.002 - 32 µg/mL
  17.  K190252  MTS Gentamicin 0.016 - 256 µg/mL
  18.  K190914  MTS Doxycycline 0.016 - 256 µg/mL
  19.  K191809  MTS Imipenem-relebactam 0.002/4-32/4 µg/mL
  20.  K192345  MTS Ampicillin-Sulbactam 0.016/0.008 - 256/128 µg/ ...
  21.  K200180  MTS Omadacycline 0.002 - 32 ug/mL
  22.  K211672  MTS Piperacillin-tazobactam 0.016/4 - 256/4µg/mL
LIOFILCHEM S.R.L
  SUBSTANTIALLY EQUIVALENT 2
LIOFILCHEM S.R.L.
  SUBSTANTIALLY EQUIVALENT 7
THERMO FISHER SCIENTIFIC
  SUBSTANTIALLY EQUIVALENT 32
TREK DIAGNOSTIC SYSTEMS
  SUBSTANTIALLY EQUIVALENT 2
TREK DIAGNOSTIC SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 2
TREK DIAGNOSTIC SYSTEMS, LTD.
  SUBSTANTIALLY EQUIVALENT 3

MDR Year MDR Reports MDR Events
2014 4 4
2015 11 11
2016 20 20
2017 9 9
2018 13 13
2019 10 10
2020 20 20
2021 41 41
2022 11 11
2023 9 9

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect, Inadequate or Imprecise Result or Readings 103 103
Incorrect Or Inadequate Test Results 17 17
Low Test Results 9 9
High Test Results 8 8
Low Readings 3 3
High Readings 2 2
Device Inoperable 2 2
Volume Accuracy Problem 1 1
False Positive Result 1 1
False Reading From Device Non-Compliance 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Protective Measures Problem 1 1
Insufficient Information 1 1
Appropriate Term/Code Not Available 1 1
Component Misassembled 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 58 58
No Known Impact Or Consequence To Patient 53 53
No Patient Involvement 19 19
No Consequences Or Impact To Patient 11 11
Not Applicable 3 3
Insufficient Information 2 2
No Information 1 1
No Code Available 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Beckman Coulter Inc. II Oct-02-2018
2 Beckman Coulter, Inc. II Apr-27-2015
3 Beckman Coulter, Inc. II Apr-27-2015
4 Beckman Coulter, Inc. II Apr-26-2015
5 Becton Dickinson & Co. II Dec-23-2015
6 Becton Dickinson & Co. II Sep-12-2014
7 Becton Dickinson & Co. II Jul-24-2013
8 BioMerieux SA II Dec-19-2017
9 BioMerieux SA II May-03-2017
10 BioMerieux SA II May-03-2017
11 BioMerieux SA II Mar-21-2017
12 BioMerieux SA II Feb-21-2017
13 BioMerieux SA II Jul-01-2015
14 Biomerieux I Dec-23-2015
15 Biomerieux III Nov-19-2014
16 Biomerieux Inc II Jan-04-2023
17 Biomerieux Inc II Aug-06-2021
18 Remel Inc I Dec-08-2022
19 Remel Inc II Mar-04-2022
20 Siemens Healthcare Diagnostics, Inc. II May-08-2012
21 Siemens Microscan II Feb-04-2009
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