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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device antigen, c. difficile
Product CodeMCB
Regulation Number 866.2660
Device Class 1

MDR Year MDR Reports MDR Events
2021 2 2
2022 2 2
2023 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
False Negative Result 5 5
Device Markings/Labelling Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 6 6

Recalls
Manufacturer Recall Class Date Posted
1 bioMerieux, Inc. II Dec-28-2021
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