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TPLC
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Device
single (specified) analyte controls (assayed and unassayed)
Regulation Description
Quality control material (assayed and unassayed).
Product Code
JJX
Regulation Number
862.1660
Device Class
1
MDR Year
MDR Reports
MDR Events
2020
77
77
2021
43
43
2022
24
24
2023
22
22
2024
30
30
2025
1
1
Device Problems
MDRs with this Device Problem
Events in those MDRs
Incorrect, Inadequate or Imprecise Result or Readings
168
168
Missing Information
5
5
Appropriate Term/Code Not Available
4
4
Improper or Incorrect Procedure or Method
4
4
Adverse Event Without Identified Device or Use Problem
3
3
False Positive Result
2
2
Defective Device
1
1
Product Quality Problem
1
1
Device Markings/Labelling Problem
1
1
False Negative Result
1
1
Insufficient Information
1
1
Ambient Temperature Problem
1
1
Premature Discharge of Battery
1
1
Labelling, Instructions for Use or Training Problem
1
1
Use of Device Problem
1
1
Inadequate Instructions for Non-Healthcare Professional
1
1
Display or Visual Feedback Problem
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
124
124
No Known Impact Or Consequence To Patient
56
56
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
3
3
Insufficient Information
3
3
Hypoglycemia
2
2
Erythema
2
2
Hyperglycemia
1
1
Unspecified Infection
1
1
Dry Eye(s)
1
1
Neuropathy
1
1
Swelling/ Edema
1
1
Laceration(s)
1
1
Burn(s)
1
1
Rupture
1
1
Red Eye(s)
1
1
No Code Available
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Abbott Laboratories
III
May-05-2020
2
Mckesson Medical-Surgical Inc. Corporate Office
II
Mar-19-2024
3
Medline Industries Inc
III
Feb-19-2021
4
Ortho-Clinical Diagnostics, Inc.
III
Jun-04-2024
5
Ortho-Clinical Diagnostics, Inc.
III
Jul-21-2023
6
Ortho-Clinical Diagnostics, Inc.
III
Nov-17-2021
7
Sentinel CH SpA
III
Jul-06-2021
8
Siemens Healthcare Diagnostics, Inc.
II
Feb-21-2023
9
Tosoh Bioscience Inc
II
Sep-14-2020
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