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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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New Search show TPLC since Back to Search Results
Device enzyme immunoassay, tracrolimus
Regulation Description Tacrolimus test system.
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
2021 1 1
2022 23 27
2023 54 56
2024 62 62
2025 8 8
2026 5 5

Device Problems MDRs with this Device Problem Events in those MDRs
Low Test Results 75 79
High Test Results 55 56
Imprecision 25 25
Incorrect, Inadequate or Imprecise Result or Readings 11 12
Non Reproducible Results 8 9
Incorrect Measurement 2 2
Output Problem 1 1
Device Damaged Prior to Use 1 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 143 149
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 6 6
Insufficient Information 4 4

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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