TPLC - Total Product Life Cycle

• Device: system, test, carcinoembryonic antigen
• Product Code: DHX
• Regulation Number: 866.6010
• Device Class: 2

Premarket Reviews
Manufacturer	Decision
BECKMAN COULTER, INC
	SUBSTANTIALLY EQUIVALENT	1
OLYMPUS AMERICA, INC.
	SUBSTANTIALLY EQUIVALENT	1
ORTHO CLINICAL DIAGNOSTICS
	SUBSTANTIALLY EQUIVALENT	1
SIEMENS HEALTHCARE DISGNOSTICS INC.
	SUBSTANTIALLY EQUIVALENT	1

MDR Year	MDR Reports	MDR Events
2014	15	15
2015	33	33
2016	22	22
2017	7	7
2018	20	20
2019	12	12
2020	14	14
2021	11	11
2022	12	12
2023	16	16
2024	1	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
High Test Results	53	53
Low Test Results	51	51
No Apparent Adverse Event	17	17
Adverse Event Without Identified Device or Use Problem	11	11
False Negative Result	11	11
Incorrect, Inadequate or Imprecise Result or Readings	10	10
Incorrect Or Inadequate Test Results	7	7
Non Reproducible Results	3	3
False Reading From Device Non-Compliance	2	2
Incorrect Measurement	1	1
Mechanical Problem	1	1
Nonstandard Device	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Known Impact Or Consequence To Patient	85	85
No Clinical Signs, Symptoms or Conditions	38	38
No Consequences Or Impact To Patient	25	25
No Code Available	15	15
Missing Value Reason	1	1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1
Test Result	1	1
No Information	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Beckman Coulter Inc.	II	Nov-06-2015
2	BioCheck Inc	II	Mar-11-2011
3	Siemens Healthcare Diagnostics, Inc.	II	May-04-2018
4	Tosoh Bioscience Inc	II	Jun-05-2018