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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device products, red-cell lysing products
Product CodeGGK
Regulation Number 864.8540
Device Class 1

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

Device Problems MDRs with this Device Problem Events in those MDRs
Device Markings/Labelling Problem 2 2
Fluid/Blood Leak 1 1
Device Contamination with Chemical or Other Material 1 1
High Test Results 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 3 3
No Patient Involvement 1 1
No Known Impact Or Consequence To Patient 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Beckman Coulter Inc. II Sep-19-2011
2 Beckman Coulter Inc. II May-20-2011
3 Beckman Coulter Inc. II May-19-2011
4 Mckesson Medical-Surgical Inc. Corporate Office II Aug-26-2022
5 Sysmex America, Inc. II Aug-23-2011
6 Sysmex America, Inc. II Jul-13-2011
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