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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device alpha-1-lipoprotein, antigen, antiserum, control
Product CodeDER
Regulation Number 866.5580
Device Class 2

MDR Year MDR Reports MDR Events
2023 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect Measurement 1 1
Incorrect, Inadequate or Imprecise Result or Readings 1 1
High Test Results 1 1
No Apparent Adverse Event 1 1
Non Reproducible Results 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Abbott Laboratories, Inc II Jul-19-2019
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