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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device acid, uric, uricase (colorimetric)
Product CodeKNK
Regulation Number 862.1775
Device Class 1


Premarket Reviews
ManufacturerDecision
ABBOTT LABORATORIES
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 1 1
2020 2 2
2022 1 1
2023 4 4
2024 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Non Reproducible Results 5 5
Low Test Results 3 3
High Test Results 2 2
Device Difficult to Setup or Prepare 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 6 6
No Consequences Or Impact To Patient 3 3

Recalls
Manufacturer Recall Class Date Posted
1 Beckman Coulter Inc II Mar-02-2020
2 Beckman Coulter Inc. II Oct-24-2019
3 Beckman Coulter Inc. II May-12-2017
4 Beckman Coulter Inc. II Jun-08-2016
5 Beckman Coulter Inc. II Jan-28-2015
6 Horiba Instruments Inc II Feb-02-2016
7 Ortho-Clinical Diagnostics II Oct-17-2016
8 Ortho-Clinical Diagnostics II Nov-15-2013
9 Pointe Scientific, Inc. II Mar-02-2010
10 Roche Diagnostics Operations, Inc. II Jun-27-2015
11 Siemens Healthcare Diagnostics, Inc. II May-11-2016
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