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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
2019 8 8
2020 3 3
2021 12 12
2022 7 7
2023 4 4

Device Problems MDRs with this Device Problem Events in those MDRs
Low Test Results 19 19
High Test Results 11 11
Incorrect, Inadequate or Imprecise Result or Readings 3 3
Improper or Incorrect Procedure or Method 3 3

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 24 24
No Known Impact Or Consequence To Patient 8 8
Renal Failure 2 2

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