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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device antisera, fluorescent, all, mycoplasma spp.
Product CodeGRZ
Regulation Number 866.3375
Device Class 1

MDR Year MDR Reports MDR Events
2023 15 15
2024 23 23

Device Problems MDRs with this Device Problem Events in those MDRs
Low Test Results 27 27
Incorrect, Inadequate or Imprecise Result or Readings 3 3
High Test Results 2 2
Smoking 1 1
Thermal Decomposition of Device 1 1
Leak/Splash 1 1
Installation-Related Problem 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Patient Data Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 37 37
Laceration(s) 1 1

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