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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device kit, identification, enterobacteriaceae
Product CodeJSS
Regulation Number 866.2660
Device Class 1

MDR Year MDR Reports MDR Events
2019 3 3
2020 8 8
2021 9 9
2022 2 2
2023 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect, Inadequate or Imprecise Result or Readings 20 20
Incorrect Measurement 2 2
Unable to Obtain Readings 1 1
Device Markings/Labelling Problem 1 1
Inaccurate Information 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Patient Involvement 10 10
No Clinical Signs, Symptoms or Conditions 10 10
No Known Impact Or Consequence To Patient 3 3

Recalls
Manufacturer Recall Class Date Posted
1 Biomerieux Inc II Jan-04-2023
2 Biomerieux Inc II Dec-27-2021
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