TPLC - Total Product Life Cycle

• Device: azo dye, calcium
• Product Code: CJY
• Regulation Number: 862.1145
• Device Class: 2

Premarket Reviews
Manufacturer	Decision
ELITECHGROUP
	SUBSTANTIALLY EQUIVALENT	1
HORIBA ABX S.A.S.
	SUBSTANTIALLY EQUIVALENT	1
HORIBA ABX SAS
	SUBSTANTIALLY EQUIVALENT	1
RANDOX LABORATORIES LTD.
	SUBSTANTIALLY EQUIVALENT	1
SIEMENS HEALTHCARE DIAGNOSTICS
	SUBSTANTIALLY EQUIVALENT	1
VITAL DIAGNOSTICS (MANUFACTURING) PTY LTD
	SUBSTANTIALLY EQUIVALENT	1

MDR Year	MDR Reports	MDR Events
2014	5	5
2015	4	4
2016	3	3
2017	26	26
2018	21	21
2019	29	29
2020	33	33
2021	24	24
2022	17	17
2023	29	29
2024	10	10

Device Problems	MDRs with this Device Problem	Events in those MDRs
High Test Results	100	100
Low Test Results	87	87
Incorrect Or Inadequate Test Results	4	4
Packaging Problem	4	4
Adverse Event Without Identified Device or Use Problem	3	3
Incorrect, Inadequate or Imprecise Result or Readings	3	3
Fluid/Blood Leak	1	1
High Readings	1	1
Low Readings	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Known Impact Or Consequence To Patient	97	97
No Clinical Signs, Symptoms or Conditions	84	84
No Consequences Or Impact To Patient	19	19
Test Result	2	2
Insufficient Information	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Ortho-Clinical Diagnostics	II	Jul-23-2016
2	Ortho-Clinical Diagnostics	II	Nov-15-2013
3	Randox Laboratories Ltd.	II	Feb-15-2019
4	SEPPIM SAS	II	Nov-07-2013
5	Siemens Healthcare Diagnostics, Inc.	II	Apr-14-2022
6	Vital Diagnostics, Inc.	II	Jan-14-2014