TPLC - Total Product Life Cycle

• Device: bromcresol green dye-binding, albumin
• Product Code: CIX
• Regulation Number: 862.1035
• Device Class: 2

Premarket Reviews
Manufacturer	Decision
ABBOTT IRELAND DIAGNOSTICS DIVISION
	SUBSTANTIALLY EQUIVALENT	1
ALFA WASSERMANN DIAGNOSTIC TECHNOLOGIES, INC.
	SUBSTANTIALLY EQUIVALENT	1
ALFA WASSERMANN DIAGNOSTICS TECHNOLOGIES, LLC
	SUBSTANTIALLY EQUIVALENT	1
BIOSYSTEMS S.A.
	SUBSTANTIALLY EQUIVALENT	1
ELITECHGROUP
	SUBSTANTIALLY EQUIVALENT	1
MEDICA CORP.
	SUBSTANTIALLY EQUIVALENT	2
MEDICON HELLAS, S.A
	SUBSTANTIALLY EQUIVALENT	1
ORTHO-CLINICAL DIAGNOSTICS, INC.
	SUBSTANTIALLY EQUIVALENT	1
POLYMEDCO, INC.
	SUBSTANTIALLY EQUIVALENT	1

MDR Year	MDR Reports	MDR Events
2016	1	1
2017	5	5
2018	2	2
2020	1	1
2021	3	3
2022	1	1
2023	5	5
2024	1	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Low Test Results	13	13
Incorrect, Inadequate or Imprecise Result or Readings	4	4
Non Reproducible Results	3	3
High Test Results	2	2
Adverse Event Without Identified Device or Use Problem	2	2
Unexpected Therapeutic Results	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	10	10
No Known Impact Or Consequence To Patient	6	6
No Consequences Or Impact To Patient	3	3

Recalls
Manufacturer		Recall Class	Date Posted
1	Abbott Laboratories Inc.	II	Apr-18-2012
2	Ortho-Clinical Diagnostics	II	Nov-15-2013
3	Roche Diagnostics Operations, Inc.	III	Oct-13-2020
4	Roche Diagnostics Operations, Inc.	III	Oct-16-2019