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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device enzyme immunoassay, tracrolimus
Product CodeMLM
Regulation Number 862.1678
Device Class 2


Premarket Reviews
ManufacturerDecision
SHANGHAI GENEXT MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 7 7
2020 4 4
2021 1 1
2022 23 23
2023 55 55
2024 34 34

Device Problems MDRs with this Device Problem Events in those MDRs
Low Test Results 65 65
High Test Results 42 42
Imprecision 25 25
Incorrect, Inadequate or Imprecise Result or Readings 6 6
Non Reproducible Results 3 3
Incorrect Measurement 2 2
Device Damaged Prior to Use 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 108 108
No Consequences Or Impact To Patient 8 8
Insufficient Information 4 4
No Known Impact Or Consequence To Patient 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Microgenics Corporation II Jun-24-2022
2 Siemens Healthcare Diagnostics, Inc. II Mar-15-2023
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