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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
ROCHE DIAGNOSTICS
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2017 2 2
2018 26 26
2019 7 7
2020 4 4
2021 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
High Test Results 37 37
Low Test Results 3 3
Non Reproducible Results 1 1
Incorrect Measurement 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 20 20
No Known Impact Or Consequence To Patient 19 19
No Clinical Signs, Symptoms or Conditions 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Siemens Healthcare Diagnostics, Inc. II May-04-2018
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