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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
2020 89 89
2021 4 4

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect, Inadequate or Imprecise Result or Readings 90 90
Sparking 1 1
Output Problem 1 1
Appropriate Term/Code Not Available 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 50 50
No Patient Involvement 32 32
No Consequences Or Impact To Patient 6 6
No Clinical Signs, Symptoms or Conditions 4 4
No Information 1 1

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