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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device calibrator, secondary
Product CodeJIT
Regulation Number 862.1150
Device Class 2


Premarket Reviews
ManufacturerDecision
ABBOTT LABORATORIES
  SUBSTANTIALLY EQUIVALENT 3
BECKMAN COULTER IRELAND INC
  SUBSTANTIALLY EQUIVALENT 1
BECKMAN COULTER, INC.
  SUBSTANTIALLY EQUIVALENT 2
BIOKIT S.A.
  SUBSTANTIALLY EQUIVALENT 1
DIAGNOSTICA STAGO, INC.
  SUBSTANTIALLY EQUIVALENT 1
DIAMOND DIAGNOSTICS, INC
  SUBSTANTIALLY EQUIVALENT 3
DIAMOND DIAGNOSTICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
DIAZYME LABORATORIES
  SUBSTANTIALLY EQUIVALENT 2
ELITECHGROUP
  SUBSTANTIALLY EQUIVALENT 1
FUJIREBIO DIAGNOSTICS, INC
  SUBSTANTIALLY EQUIVALENT 1
FUJIREBIO DIAGNOSTICS, INC.
  SUBSTANTIALLY EQUIVALENT 4
HORIBA ABX SAS
  SUBSTANTIALLY EQUIVALENT 1
MITSUBISHI CHEMICAL MEDIENCE CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
ORTHO CLINICAL DIAGNOSTICS
  SUBSTANTIALLY EQUIVALENT 1
RANDOX LABORATORIES LIMITED
  SUBSTANTIALLY EQUIVALENT 1
ROCHE DIAGNOSTICS
  SUBSTANTIALLY EQUIVALENT 6
SEKISUI DIAGNOSTICS P.E.I. INC.
  SUBSTANTIALLY EQUIVALENT 1
SENTINEL CH. SPA
  SUBSTANTIALLY EQUIVALENT 1
SIEMENS CORP.
  SUBSTANTIALLY EQUIVALENT 1
SIEMENS HEALTHCARE DIAGNOSTICS
  SUBSTANTIALLY EQUIVALENT 4
SIEMENS HEALTHCARE DIAGNOSTICS INC
  SUBSTANTIALLY EQUIVALENT 1
SIEMENS HEALTHCARE DIAGNOSTICS INC.
  SUBSTANTIALLY EQUIVALENT 2
SIEMENS HEATLHCARE DIAGNOSTICS INC
  SUBSTANTIALLY EQUIVALENT 1
TOSOH BIOSCIENCE, INC.
  SUBSTANTIALLY EQUIVALENT 5

MDR Year MDR Reports MDR Events
2014 9 9
2015 6 6
2016 3 3
2017 7 7
2018 8 8
2019 215 215
2020 12 12
2021 3 3
2022 4 4
2023 6 6
2024 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
High Test Results 234 234
Low Test Results 18 18
Calibration Problem 14 14
Incorrect, Inadequate or Imprecise Result or Readings 9 9
Adverse Event Without Identified Device or Use Problem 5 5
Failure to Calibrate 2 2
Use of Device Problem 1 1
High Readings 1 1
Device Ingredient or Reagent Problem 1 1
Device Issue 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Patient Involvement 200 200
No Known Impact Or Consequence To Patient 43 43
No Clinical Signs, Symptoms or Conditions 19 19
No Consequences Or Impact To Patient 9 9
No Code Available 2 2
Exposure to Body Fluids 2 2
Eye Injury 2 2

Recalls
Manufacturer Recall Class Date Posted
1 Abbott Laboratories III May-05-2020
2 Abbott Laboratories II Apr-09-2020
3 Abbott Laboratories III Jul-25-2019
4 Abbott Laboratories III May-16-2019
5 Abbott Laboratories II May-29-2014
6 Beckman Coulter Inc. II Oct-10-2012
7 Beckman Coulter Inc. II Mar-20-2012
8 Beckman Coulter Inc. II May-20-2011
9 Beckman Coulter Inc. II May-10-2011
10 Immunodiagnostics Systems Ltd II Oct-10-2012
11 Medica Corporation II Mar-28-2018
12 Ortho-Clinical Diagnostics II Jul-11-2023
13 Ortho-Clinical Diagnostics III Feb-09-2017
14 Ortho-Clinical Diagnostics III Sep-15-2016
15 Ortho-Clinical Diagnostics III Nov-02-2015
16 Ortho-Clinical Diagnostics II Jun-16-2014
17 Ortho-Clinical Diagnostics III Mar-12-2014
18 Ortho-Clinical Diagnostics II Feb-07-2012
19 Ortho-Clinical Diagnostics, Inc. II Jan-11-2024
20 Randox Laboratories Ltd. II Apr-17-2024
21 Randox Laboratories Ltd. II Mar-15-2019
22 Siemens Healthcare Diagnostics, Inc II Apr-19-2017
23 Siemens Healthcare Diagnostics, Inc II Jun-06-2013
24 Siemens Healthcare Diagnostics, Inc. II Aug-24-2023
25 Siemens Healthcare Diagnostics, Inc. II Oct-13-2020
26 Siemens Healthcare Diagnostics, Inc. II Jan-29-2019
27 Siemens Healthcare Diagnostics, Inc. III Feb-16-2017
28 Siemens Healthcare Diagnostics, Inc. II Jan-08-2015
29 Siemens Healthcare Diagnostics, Inc. II Oct-06-2014
30 Siemens Healthcare Diagnostics, Inc. II Jun-26-2014
31 Siemens Healthcare Diagnostics, Inc. II Aug-07-2013
32 Siemens Healthcare Diagnostics, Inc. III Mar-25-2013
33 Siemens Healthcare Diagnostics, Inc. II Jan-11-2012
34 Tosoh Bioscience Inc II Sep-14-2020
35 Tosoh Bioscience Inc II May-14-2018
36 Tosoh Bioscience, Inc. III Jul-25-2016
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