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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device instrument for auto reader & interpretation of overnight suscept. systems
Product CodeLRG
Regulation Number 866.1640
Device Class 2


Premarket Reviews
ManufacturerDecision
THERMO FISHER SCIENTIFIC
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2019 3 3
2020 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Device Handling Problem 2 2
Incorrect, Inadequate or Imprecise Result or Readings 1 1
Device Misassembled During Manufacturing /Shipping 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Injury 2 2
No Patient Involvement 1 1
Not Applicable 1 1
Septic Shock 1 1
Urinary Tract Infection 1 1
No Consequences Or Impact To Patient 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Beckman Coulter Inc. II May-13-2022
2 Beckman Coulter Inc. II Apr-07-2021
3 Beckman Coulter Inc. II Dec-23-2020
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