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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device calibrator, primary
Product CodeJIS
Regulation Number 862.1150
Device Class 2


Premarket Reviews
ManufacturerDecision
RANDOX LABORATORIES LIMITED
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2015 1 1
2016 1 1
2017 3 3
2018 7 7
2019 1 1
2020 1 1
2022 11 11
2024 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Calibration Problem 12 12
Low Test Results 8 8
High Test Results 3 3
Device Ingredient or Reagent Problem 1 1
High Readings 1 1
Incorrect, Inadequate or Imprecise Result or Readings 1 1
Improper or Incorrect Procedure or Method 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 13 13
No Clinical Signs, Symptoms or Conditions 11 11
Hematoma 1 1
No Consequences Or Impact To Patient 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Abbott Laboratories II Apr-07-2022
2 Beckman Coulter Inc. II Nov-15-2016
3 Beckman Coulter Inc. II Dec-22-2012
4 Beckman Coulter Inc. II Jun-21-2011
5 Fujifilm Medical Systems U.S.A., Inc. III Jan-28-2021
6 Ortho Clinical Diagnostics Inc II Feb-15-2019
7 Sentinel CH SpA III Oct-06-2021
8 Siemens Healthcare Diagnostics, Inc III Aug-14-2013
9 Siemens Healthcare Diagnostics, Inc II Apr-15-2013
10 Siemens Healthcare Diagnostics, Inc. III Mar-15-2017
11 Siemens Healthcare Diagnostics, Inc. III Jan-29-2013
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