Quick Links: Skip to main page content
Skip to Search
Skip to Topics Menu
Skip to Common Links
U.S. Food & Drug Administration
Follow FDA
En Español
Search FDA
Home
Food
Drugs
Medical Devices
Radiation-Emitting Products
Vaccines, Blood & Biologics
Animal & Veterinary
Cosmetics
Tobacco Products
TPLC - Total Product Life Cycle
FDA Home
medical devices
databases
-
510(k)
|
DeNovo
|
Registration & Listing
|
Adverse Events
|
Recalls
|
PMA
|
HDE
|
Classification
|
Standards
CFR Title 21
|
Radiation-Emitting Products
|
X-Ray Assembler
|
Medsun Reports
|
CLIA
|
TPLC
New Search
show TPLC since
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
Back to Search Results
Device
calibrator, multi-analyte mixture
Product Code
JIX
Regulation Number
862.1150
Device Class
2
MDR Year
MDR Reports
MDR Events
2019
12
12
2020
22
22
2021
9
9
2022
11
11
2023
13
13
2024
10
10
Device Problems
MDRs with this Device Problem
Events in those MDRs
High Test Results
54
54
Low Test Results
14
14
Incorrect, Inadequate or Imprecise Result or Readings
4
4
Defective Component
2
2
Non Reproducible Results
2
2
High Readings
2
2
Device Sensing Problem
1
1
Material Split, Cut or Torn
1
1
No Device Output
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
50
50
No Known Impact Or Consequence To Patient
23
23
No Consequences Or Impact To Patient
3
3
Laceration(s)
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Chromsystems Instruments & Chemicals GmbH
II
Dec-04-2020
2
Chromsystems Instruments & Chemicals GmbH
II
Dec-02-2020
3
Ortho Clinical Diagnostics
II
Aug-06-2019
4
Ortho Clinical Diagnostics Inc
II
Feb-13-2020
5
Ortho-Clinical Diagnostics, Inc.
II
Mar-23-2021
6
Randox Laboratories Ltd.
II
May-03-2024
7
Randox Laboratories Ltd.
II
Mar-20-2024
8
Randox Laboratories Ltd.
II
Jan-18-2024
9
Randox Laboratories Ltd.
II
Jan-18-2024
10
Randox Laboratories Ltd.
II
Jan-18-2024
11
Randox Laboratories Ltd.
II
Aug-23-2023
12
Randox Laboratories Ltd.
II
May-12-2021
13
Randox Laboratories Ltd.
II
Nov-04-2019
14
Randox Laboratories Ltd.
III
Sep-07-2019
15
Siemens Healthcare Diagnostics Inc
II
Dec-21-2023
16
Siemens Healthcare Diagnostics, Inc.
II
Feb-18-2020
-
-