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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
2019 9 9
2020 11 11
2021 7 7
2022 30 30
2023 4 4

Device Problems MDRs with this Device Problem Events in those MDRs
Unable to Obtain Readings 12 12
Incorrect, Inadequate or Imprecise Result or Readings 12 12
Nonstandard Device 11 11
Low Test Results 7 7
Use of Device Problem 4 4
False Negative Result 3 3
False Positive Result 3 3
Off-Label Use 1 1
Failure to Calibrate 1 1
High Test Results 1 1
High Readings 1 1
Device Markings/Labelling Problem 1 1
Installation-Related Problem 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Non Reproducible Results 1 1
Use of Incorrect Control/Treatment Settings 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 39 39
No Known Impact Or Consequence To Patient 12 12
No Consequences Or Impact To Patient 3 3
No Patient Involvement 3 3
Hypersensitivity/Allergic reaction 1 1
Laceration(s) 1 1
No Code Available 1 1
Insufficient Information 1 1

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