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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device system, hemoglobin, automated
Product CodeGKR
Regulation Number 864.5620
Device Class 2


Premarket Reviews
ManufacturerDecision
EKF-DIAGNOSTIC GMBH
  SUBSTANTIALLY EQUIVALENT 3
HEMOCUE AB
  SUBSTANTIALLY EQUIVALENT 2
IMMUNOSTICS, INC.
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2019 9 9
2020 1 1
2021 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Computer Software Problem 8 8
Solder Joint Fracture 8 8
Adverse Event Without Identified Device or Use Problem 2 2
Incorrect Measurement 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 8 8
No Code Available 1 1
Cardiac Arrest 1 1
No Consequences Or Impact To Patient 1 1
Loss of consciousness 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Siemens Healthcare Diagnostics, Inc. II Aug-24-2018
2 Stanbio Laboratory, LP II Aug-24-2018
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