TPLC - Total Product Life Cycle

• Device: photometric method, magnesium
• Product Code: JGJ
• Regulation Number: 862.1495
• Device Class: 1

Premarket Reviews
Manufacturer	Decision
ABAXIS, INC.
	SUBSTANTIALLY EQUIVALENT	1
ABBOTT LABORATORIES
	SUBSTANTIALLY EQUIVALENT	2
ALFA WASSERMANN DIAGNOSTICS TECHNOLOGIES, LLC
	SUBSTANTIALLY EQUIVALENT	1
MEDICA CORP.
	SUBSTANTIALLY EQUIVALENT	1
RANDOX LABORATORIES LTD
	SUBSTANTIALLY EQUIVALENT	1
SEKISUI DIAGNOSTICS P.E.I. INC.
	SUBSTANTIALLY EQUIVALENT	1
SIEMENS HEALTHCARE DIAGNOSTICS, INC.
	SUBSTANTIALLY EQUIVALENT	1

MDR Year	MDR Reports	MDR Events
2014	4	4
2015	24	24
2016	4	4
2017	18	18
2018	21	21
2019	31	31
2020	34	34
2021	33	33
2022	42	42
2023	32	32
2024	8	8

Device Problems	MDRs with this Device Problem	Events in those MDRs
High Test Results	187	187
Low Test Results	34	34
Incorrect, Inadequate or Imprecise Result or Readings	25	25
Incorrect Or Inadequate Test Results	7	7
Non Reproducible Results	3	3
Crack	1	1
Degraded	1	1
False Positive Result	1	1
Leak/Splash	1	1
Mechanical Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	107	107
No Known Impact Or Consequence To Patient	96	96
No Consequences Or Impact To Patient	35	35
Insufficient Information	7	7
No Code Available	3	3
No Patient Involvement	2	2
Misdiagnosis	2	2

Recalls
Manufacturer		Recall Class	Date Posted
1	Abbott Laboratories, Inc	II	Mar-01-2019
2	Beckman Coulter Inc.	II	Feb-28-2022
3	Horiba Instruments, Inc dba Horiba Medical	II	Sep-24-2014
4	Ortho-Clinical Diagnostics	II	Nov-15-2013
5	Randox Laboratories Ltd.	II	Dec-08-2020
6	Randox Laboratories, Limited	II	Dec-08-2016
7	Siemens Healthcare Diagnostics, Inc.	II	Sep-26-2022
8	Siemens Healthcare Diagnostics, Inc.	II	Mar-28-2022
9	Siemens Healthcare Diagnostics, Inc.	II	Nov-25-2015
10	Siemens Healthcare Diagnostics, Inc.	II	Apr-17-2012