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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Super Search Devices@FDA
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New Search Show TPLC since Back To Search Results
Device system, hemoglobin, automated
Regulation Description Automated hemoglobin system.
Product CodeGKR
Regulation Number 864.5620
Device Class 2


Premarket Reviews
ManufacturerDecision
EKF-DIAGNOSTIC GMBH
  SUBSTANTIALLY EQUIVALENT 1
IMMUNOSTICS, INC.
  SUBSTANTIALLY EQUIVALENT 2
RADIOMETER MEDICAL APS
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Computer Software Problem 7
Solder Joint Fracture 7
Incorrect, Inadequate or Imprecise Result or Readings 5
High Test Results 3
Low Test Results 2
Device Issue 1
Device Handling Problem 1
Incorrect Or Inadequate Test Results 1
Output Problem 1
Adverse Event Without Identified Device or Use Problem 1
Total Device Problems 29

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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