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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device culture media, non-selective and non-differential
Regulation Description Multipurpose culture medium.
Product CodeJSG
Regulation Number 866.2300
Device Class 1

MDR Year MDR Reports MDR Events
2016 1 1
2017 3 3
2019 25 25

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect, Inadequate or Imprecise Resultor Readings 15 15
Microbial Contamination of Device 3 3
Device Contamination with Chemical or Other Material 3 3
Output Problem 2 2
False Negative Result 2 2
Material Opacification 2 2
False Positive Result 1 1
Tube 1 1
Break 1 1
Protective Measures Problem 1 1
Sediment, Precipitate Or Deposit In Device Or Device Ingredient 1 1
Insufficient Information 1 1
Device Contaminated During Manufacture or Shipping 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Contamination /Decontamination Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 23 23
Bacterial Infection 2 2
Unspecified Infection 1 1
Injury 1 1
No Information 1 1
Increased Sensitivity 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Acumedia Manufacturers, Inc. III Jun-01-2017
2 Acumedia Manufacturers, Inc. III Jun-01-2017
3 Acumedia Manufacturers, Inc. II Jan-25-2017
4 Becton Dickinson & Co. II Nov-30-2018
5 Becton Dickinson & Co. III Apr-26-2017
6 Becton Dickinson & Co. II Jan-14-2015
7 Remel Inc II May-22-2019
8 Remel Inc II May-20-2019
9 Remel Inc II Sep-07-2018
10 Remel Inc II Jun-10-2015
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