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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device system, mass spectrometry, maldi tof, microorganism identification, cultured isolates
Regulation Description Mass spectrometer system for clinical use for the identification of microorganisms.
Definition A mass spectrometer system using matrix-assisted laser desorption/ ionization - time of flight (MALDI-TOF) for the identification of microorganisms cultured from human specimens.
Product CodePEX
Regulation Number 866.3361
Device Class 2

MDR Year MDR Reports MDR Events
2021 4 4

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect, Inadequate or Imprecise Result or Readings 3 3
Appropriate Device Problem Term/Code Not Available 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 4 4

Recalls
Manufacturer Recall Class Date Posted
1 Biomerieux Inc II Jan-04-2023
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