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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
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 17 17
Incorrect Measurement 2 2
Device Markings/Labelling Problem 1 1
Unable to Obtain Readings 1 1
Inaccurate Information 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 10 10
No Patient Involvement 8 8
No Known Impact Or Consequence To Patient 2 2

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