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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device diluent, blood cell
Product CodeGIF
Regulation Number 864.8200
Device Class 1

MDR Year MDR Reports MDR Events
2014 124 124
2015 2 2
2021 1 1
2022 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Nonstandard Device 109 109
Device Operates Differently Than Expected 108 108
High Test Results 13 13
Device Ingredient or Reagent Problem 7 7
Device Displays Incorrect Message 4 4
Incorrect Or Inadequate Test Results 2 2
Operating System Becomes Nonfunctional 1 1
Device Handling Problem 1 1
Contamination /Decontamination Problem 1 1
Output above Specifications 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 70 70
No Consequences Or Impact To Patient 57 57
Not Applicable 7 7
No Clinical Signs, Symptoms or Conditions 1 1
Injury 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Beckman Coulter Inc. II Aug-28-2015
2 Beckman Coulter Inc. II May-15-2015
3 Beckman Coulter Inc. II Sep-16-2014
4 Beckman Coulter, Inc. II Jul-12-2023
5 Mindray DS USA, Inc. dba Mindray North America II Apr-09-2018
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