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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device lambda, antigen, antiserum, control
Product CodeDEH
Regulation Number 866.5550
Device Class 2

MDR Year MDR Reports MDR Events
2020 3 3
2021 12 12
2022 7 7
2023 4 4
2024 26 26

Device Problems MDRs with this Device Problem Events in those MDRs
Low Test Results 37 37
Incorrect, Inadequate or Imprecise Result or Readings 6 6
High Test Results 6 6
Improper or Incorrect Procedure or Method 3 3
Non Reproducible Results 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 50 50
Renal Failure 2 2

Recalls
Manufacturer Recall Class Date Posted
1 The Binding Site Group, Ltd. II Nov-19-2021
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