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
single (specified) analyte controls (assayed and unassayed)
Product Code
JJX
Regulation Number
862.1660
Device Class
1
MDR Year
MDR Reports
MDR Events
2019
82
82
2020
77
77
2021
43
43
2022
24
24
2023
22
22
2024
4
4
Device Problems
MDRs with this Device Problem
Events in those MDRs
Incorrect, Inadequate or Imprecise Result or Readings
208
208
High Test Results
14
14
Missing Information
6
6
Appropriate Term/Code Not Available
5
5
Improper or Incorrect Procedure or Method
4
4
Adverse Event Without Identified Device or Use Problem
4
4
False Positive Result
2
2
Labelling, Instructions for Use or Training Problem
1
1
Product Quality Problem
1
1
Premature Discharge of Battery
1
1
Display or Visual Feedback Problem
1
1
False Negative Result
1
1
Defective Device
1
1
Ambient Temperature Problem
1
1
Device Markings/Labelling Problem
1
1
Inadequate Instructions for Non-Healthcare Professional
1
1
Insufficient Information
1
1
Use of Device Problem
1
1
Sharp Edges
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Known Impact Or Consequence To Patient
120
120
No Clinical Signs, Symptoms or Conditions
98
98
No Patient Involvement
14
14
Insufficient Information
3
3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
3
3
Injury
2
2
Tissue Damage
2
2
Exposure to Body Fluids
2
2
Erythema
2
2
Hypoglycemia
2
2
Unspecified Infection
1
1
Laceration(s)
1
1
Neuropathy
1
1
Red Eye(s)
1
1
Hyperglycemia
1
1
Dry Eye(s)
1
1
Rupture
1
1
No Code Available
1
1
Swelling/ Edema
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Abbott Laboratories
III
May-05-2020
2
Abbott Laboratories
III
Jul-25-2019
3
Abbott Laboratories
III
May-16-2019
4
Medline Industries Inc
III
Feb-19-2021
5
Ortho-Clinical Diagnostics, Inc.
III
Jul-21-2023
6
Ortho-Clinical Diagnostics, Inc.
III
Nov-17-2021
7
Randox Laboratories Ltd.
II
Mar-15-2019
8
Sentinel CH SpA
III
Jul-06-2021
9
Siemens Healthcare Diagnostics, Inc.
II
Feb-21-2023
10
Tosoh Bioscience Inc
II
Sep-14-2020
-
-