TPLC - Total Product Life Cycle

• Device: fluorometric method, cpk or isoenzymes
• Product Code: JHX
• Regulation Number: 862.1215
• Device Class: 2

Premarket Reviews
Manufacturer	Decision
BECKMAN COULTER, INC
	SUBSTANTIALLY EQUIVALENT	1
MITSUBISHI KAGAKU IATRON
	SUBSTANTIALLY EQUIVALENT	1
ORTHO CLINICAL DIAGNOSTICS
	SUBSTANTIALLY EQUIVALENT	1
RADIOMETER MEDICAL APS
	SUBSTANTIALLY EQUIVALENT	2

MDR Year	MDR Reports	MDR Events
2014	17	17
2015	8	8
2016	10	10
2017	3	3
2018	16	16
2019	7	7
2020	3	3
2021	10	10
2022	2	2
2023	2	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
High Test Results	26	26
Incorrect Or Inadequate Test Results	14	14
Low Test Results	13	13
Incorrect, Inadequate or Imprecise Result or Readings	13	13
High Readings	5	5
False Positive Result	4	4
Adverse Event Without Identified Device or Use Problem	2	2
No Apparent Adverse Event	1	1
Noise, Audible	1	1
Computer Software Problem	1	1
Use of Device Problem	1	1
Low Readings	1	1
Device Displays Incorrect Message	1	1
Malposition of Device	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Consequences Or Impact To Patient	29	29
No Known Impact Or Consequence To Patient	29	29
No Clinical Signs, Symptoms or Conditions	15	15
No Code Available	2	2
Chest Pain	1	1
Misdiagnosis	1	1
Test Result	1	1
No Information	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Dade Behring, Inc.	II	Jan-28-2009
2	Polymedco, Inc.,/Polymedco Cancer Diagnostic Products, Llc	II	Sep-17-2018
3	Siemens Healthcare Diagnostics	II	Mar-21-2012
4	Siemens Healthcare Diagnostics Inc	II	Aug-11-2016
5	Siemens Healthcare Diagnostics Inc	II	Jan-07-2016
6	Siemens Healthcare Diagnostics, Inc.	II	Nov-10-2010
7	Tosoh Bioscience Inc	II	Jun-05-2018