TPLC - Total Product Life Cycle

• 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
2021	43	43
2022	24	25
2023	22	22
2024	30	30
2025	51	51
2026	3	3

Device Problems	MDRs with this Device Problem	Events in those MDRs
Incorrect, Inadequate or Imprecise Result or Readings	117	117
False Positive Result	30	30
Appropriate Term/Code Not Available	4	4
Adverse Event Without Identified Device or Use Problem	3	3
Missing Information	3	3
Improper or Incorrect Procedure or Method	3	3
False Negative Result	2	2
Device Markings/Labelling Problem	2	3
Inadequate Instructions for Non-Healthcare Professional	1	1
Insufficient Information	1	1
Use of Device Problem	1	1
Labelling, Instructions for Use or Training Problem	1	1
Product Quality Problem	1	2
Ambient Temperature Problem	1	2
Difficult to Open or Close	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	158	159
Insufficient Information	3	3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	2	2
Erythema	2	2
Hypoglycemia	2	2
Unspecified Infection	1	1
Red Eye(s)	1	1
Dry Eye(s)	1	1
Rupture	1	1
Burn(s)	1	1
Hyperglycemia	1	1
Laceration(s)	1	1
Swelling/ Edema	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Mckesson Medical-Surgical Inc. Corporate Office	II	May-27-2025
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