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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device system, test, automated blood grouping and antibody
Regulation Description Automated blood grouping and antibody test system.
Product CodeKSZ
Regulation Number 864.9175
Device Class 2


Premarket Reviews
ManufacturerDecision
GAMMA
  SUBSTANTIALLY EQUIVALENT 2
IMMUCOR, INC.
  SUBSTANTIALLY EQUIVALENT 15
MICRO TYPING SYSTEMS
  SUBSTANTIALLY EQUIVALENT 5
OLYMPUS
  SUBSTANTIALLY EQUIVALENT 3
  1.  BK860004  Automated Blood Grouping and Antibody Test Systems
  2.  BK870025  Automated Blood Grouping and Antibody Test Systems
  3.  BK930024  Automated Blood Grouping and Antibody Test Systems
ORTHO-CLINICAL
  SUBSTANTIALLY EQUIVALENT 1
SCHIFF & COMPANY
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
False negative result 56
False positive result 14
Failure to deliver 12
Incorrect or inadequate test results 11
Fluid leak 9
Device operates differently than expected 9
Infusion or flow issue 6
Communication or transmission issue 4
Improper or incorrect procedure or method 3
Bent 3
Incorrect or inadequate result 2
Defective component 2
Contamination of device ingredient or reagent 1
Data back-up problem 1
Defective item 1
Device displays error message 1
Air leak 1
Device clogged 1
Incorrect display 1
Excess flow or overinfusion 1
Occlusion within device 1
Program, failure to 1
Temperature issue 1
Patient Data Issue 1
Inaccurate dispensing 1
Total Device Problems 144

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