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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
Regulation Description Fibrinogen/fibrin degradation products assay.
Product CodeDAP
Regulation Number 864.7320
Device Class 2


Premarket Reviews
ManufacturerDecision
SIEMENS HEALTHCARE DIAGNOSTIC PRODUCTS GMBH
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2021 7 7
2022 30 30
2023 4 4
2024 1 1
2025 2 2
2026 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Unable to Obtain Readings 12 12
Nonstandard Device 11 11
False Negative Result 4 4
Low Test Results 4 4
Incorrect, Inadequate or Imprecise Result or Readings 3 3
False Positive Result 3 3
Non Reproducible Results 2 2
Use of Device Problem 2 2
Device Markings/Labelling Problem 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Installation-Related Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 41 41
Insufficient Information 2 2
Hypersensitivity/Allergic reaction 1 1
No Patient Involvement 1 1
Laceration(s) 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Diagnostica Stago, Inc. II Mar-19-2026
2 Diagnostica Stago, Inc. II Oct-16-2025
3 GET TESTED INTERNATIONAL AB II Dec-01-2025
4 bioMerieux, Inc. II Dec-28-2021
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