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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device fibrinogen and fibrin split products, antigen, antiserum, control
Product CodeDAP
Regulation Number 864.7320
Device Class 2

MDR Year MDR Reports MDR Events
2020 11 11
2021 7 7
2022 30 30
2023 4 4
2024 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Unable to Obtain Readings 12 12
Incorrect, Inadequate or Imprecise Result or Readings 11 11
Nonstandard Device 11 11
Low Test Results 6 6
False Negative Result 3 3
False Positive Result 3 3
Use of Device Problem 2 2
Device Markings/Labelling Problem 1 1
Non Reproducible Results 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Use of Incorrect Control/Treatment Settings 1 1
Installation-Related Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 40 40
No Known Impact Or Consequence To Patient 8 8
No Patient Involvement 2 2
Hypersensitivity/Allergic reaction 1 1
Insufficient Information 1 1
Laceration(s) 1 1

Recalls
Manufacturer Recall Class Date Posted
1 bioMerieux, Inc. II Dec-28-2021
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