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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device culture media, antimicrobial susceptibility test, excluding mueller hinton agar
Regulation Description Culture medium for antimicrobial susceptibility tests.
Product CodeJSO
Regulation Number 866.1700
Device Class 2


Premarket Reviews
ManufacturerDecision
BIOMERIEUX
  SUBSTANTIALLY EQUIVALENT 2
BIOMERIEUX SA
  SUBSTANTIALLY EQUIVALENT 1
BIOMERIEUX, INC.
  SUBSTANTIALLY EQUIVALENT 2
Bio-Rad Laboratories
  SUBSTANTIALLY EQUIVALENT 1
BIO-RAD LABORATORIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
HARDY DIAGNOSTICS
  SUBSTANTIALLY EQUIVALENT 2
THERMO FISHER SCIENTIFIC
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Incorrect, Inadequate or Imprecise Resultor Readings 51
False Positive Result 33
Incorrect Or Inadequate Test Results 27
False Negative Result 7
Contamination 2
Plate 1
Break 1
Unable to Obtain Readings 1
Total Device Problems 123

Recalls
Manufacturer Recall Class Date Posted
1 Becton Dickinson & Co. II Mar-09-2018
2 Becton Dickinson & Co. II Dec-06-2017
3 Bio-Rad Laboratories, Inc II Jun-06-2019
4 Hardy Diagnostics II Jun-09-2020
5 Hardy Diagnostics II Aug-26-2015
6 Hardy Diagnostics II Jul-29-2015
7 Hardy Diagnostics II Jul-22-2015

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