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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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New Search Show TPLC since Back To Search Results
Device culture media, non-propagating transport
Regulation Description Transport culture medium.
Product CodeJSM
Regulation Number 866.2390
Device Class 1


Premarket Reviews
ManufacturerDecision
COPAN ITALIA S.P.A.
  SUBSTANTIALLY EQUIVALENT 2
GREINER BIO-ONE NA INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDICAL CHEMICAL CORP.
  SUBSTANTIALLY EQUIVALENT 2
PURITAN MEDICAL PRODUCTS LLC
  SUBSTANTIALLY EQUIVALENT 3

Device Problems
Material Protrusion / Extrusion 30
Leak / Splash 29
Incorrect Or Inadequate Test Results 19
Short Fill 12
Delivered as Unsterile Product 11
Volume Accuracy Problem 10
Device Contamination with Chemical or Other Material 6
Device Markings / Labelling Problem 5
Component Missing 3
Use of Device Problem 2
Contamination / decontamination Problem 2
Product Quality Problem 2
Incorrect, Inadequate or Imprecise Result or Readings 2
Detachment Of Device Component 2
Material Deformation 1
Complete Blockage 1
Detachment of Device or device Component 1
Packaging Problem 1
Difficult to Insert 1
Material Discolored 1
Material Twisted / Bent 1
Appropriate Term/Code Not Available 1
Total Device Problems 143


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