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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device reagent, borrelia serological reagent
Product CodeLSR
Regulation Number 866.3830
Device Class 2


Premarket Reviews
ManufacturerDecision
BIO-RAD LABORATORIES
  SUBSTANTIALLY EQUIVALENT 1
DIASORIN INC.
  SUBSTANTIALLY EQUIVALENT 3
  1.  K193051  LIAISON Lyme Total Antibody Plus, LIAISON Lyme Tot ...
  2.  K202573  LIAISON Lyme IgM, LIAISON Lyme IgM Control Set, LI ...
  3.  K202574  LIAISON Lyme IgG, LIAISON Lyme IgG Control Set, LI ...
GOLD STANDARD DIAGNOSTICS
  SUBSTANTIALLY EQUIVALENT 6
VIRAMED BIOTECH AG
  SUBSTANTIALLY EQUIVALENT 1
ZEUS SCIENTIFIC
  SUBSTANTIALLY EQUIVALENT 1
ZEUS SCIENTIFIC INC.
  SUBSTANTIALLY EQUIVALENT 2
ZEUS SCIENTIFIC, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 15 15
2020 7 7
2021 4 4
2022 1 1
2023 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
False Negative Result 17 17
Incorrect, Inadequate or Imprecise Result or Readings 11 11
Unexpected Therapeutic Results 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 10 10
No Consequences Or Impact To Patient 8 8
No Clinical Signs, Symptoms or Conditions 6 6
No Patient Involvement 4 4
Disability 1 1
No Code Available 1 1

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