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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device station, pipetting and diluting, for clinical use
Product CodeJQW
Regulation Number 862.2750
Device Class 1

MDR Year MDR Reports MDR Events
2014 11 11
2015 6 6
2016 5 5
2017 2 2
2018 4 4
2019 2 2
2020 27 27
2021 30 30
2022 44 44
2023 36 36
2024 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Fluid/Blood Leak 47 47
Incorrect, Inadequate or Imprecise Result or Readings 43 43
Contamination 36 36
Use of Device Problem 5 5
Device Handling Problem 4 4
Device Fell 4 4
Smoking 3 3
High Test Results 3 3
Leak/Splash 3 3
Device Maintenance Issue 2 2
Inadequate Service 2 2
False Negative Result 2 2
False Positive Result 2 2
Material Integrity Problem 2 2
Misassembly During Maintenance/Repair 2 2
Non Reproducible Results 1 1
Misassembled During Installation 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Appropriate Term/Code Not Available 1 1
Device Stops Intermittently 1 1
Volume Accuracy Problem 1 1
Improper or Incorrect Procedure or Method 1 1
Failure to Deliver 1 1
Obstruction of Flow 1 1
Incorrect Or Inadequate Test Results 1 1
Failure to Align 1 1
Contamination of Device Ingredient or Reagent 1 1
Loss of Data 1 1
Device Operates Differently Than Expected 1 1
Difficult to Open or Close 1 1
Environmental Particulates 1 1
Failure to Shut Off 1 1
Inadequate User Interface 1 1
Installation-Related Problem 1 1
Fire 1 1
Fail-Safe Design Failure 1 1
Break 1 1
Failure to Capture 1 1
Component Falling 1 1
Computer Software Problem 1 1
Device Slipped 1 1
Fracture 1 1
Melted 1 1
Off-Label Use 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 120 120
No Consequences Or Impact To Patient 19 19
No Known Impact Or Consequence To Patient 16 16
No Patient Involvement 11 11
Needle Stick/Puncture 5 5
Injury 4 4
Fracture, Arm 2 2
Abrasion 2 2
Bone Fracture(s) 2 2
Physical Entrapment 1 1
Distress 1 1
Disability 1 1
Patient Problem/Medical Problem 1 1
No Information 1 1
No Code Available 1 1
Cancer 1 1
Unspecified Tissue Injury 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Abbott Molecular II Jul-14-2012
2 BD Biosciences, Systems & Reagents II Jun-25-2015
3 Beckman Coulter Inc. II Jun-26-2015
4 Beckman Coulter Inc. II Oct-12-2012
5 Beckman Coulter Inc. II Oct-01-2012
6 Beckman Coulter Inc. II Oct-07-2011
7 Beckman Coulter Inc. II Jun-04-2010
8 Bio-Rad Laboratories Inc III Mar-02-2011
9 Bio-Rad Laboratories, Inc. II Mar-18-2011
10 Hamilton Co II Feb-27-2021
11 Hologic, Inc II Oct-11-2018
12 PerkinElmer, Inc II Dec-16-2016
13 PerkinElmer, Inc II Dec-12-2016
14 Perkinelmer Life Sciences, Inc. III Feb-27-2018
15 Tecan US, Inc. II Jun-21-2019
16 Tecan US, Inc. II Oct-11-2018
17 Tecan US, Inc. II Oct-29-2014
18 Tecan US, Inc. II Jun-19-2013
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