TPLC - Total Product Life Cycle

• Device: hepatitis a test (antibody and igm antibody)
• Product Code: LOL
• Regulation Number: 866.3310
• Device Class: 2

Premarket Reviews
Manufacturer	Decision
ABBOTT LABORATORIES
	SUBSTANTIALLY EQUIVALENT	2
BIO-RAD LABORATORIES, INC.
	SUBSTANTIALLY EQUIVALENT	2
DIASORIN INC.
	SUBSTANTIALLY EQUIVALENT	4
DIASORIN, INC.
	SUBSTANTIALLY EQUIVALENT	2
ROCHE DIAGNOSTICS
	SUBSTANTIALLY EQUIVALENT	2
ROCHE PROFESSIONAL DIAGNOSTICS
	SUBSTANTIALLY EQUIVALENT	1
SIEMENS HEALTHCARE DIAGNOSTICS, INC.
	SUBSTANTIALLY EQUIVALENT	2

MDR Year	MDR Reports	MDR Events
2014	19	19
2015	28	28
2016	36	36
2017	26	26
2018	61	61
2019	51	51
2020	104	104
2021	12	12
2022	17	17
2023	36	36
2024	16	16

Device Problems	MDRs with this Device Problem	Events in those MDRs
False Positive Result	178	178
High Test Results	154	154
False Negative Result	20	20
Incorrect Or Inadequate Test Results	20	20
Adverse Event Without Identified Device or Use Problem	15	15
Incorrect, Inadequate or Imprecise Result or Readings	12	12
Non Reproducible Results	6	6
Low Test Results	6	6
False Reading From Device Non-Compliance	2	2
Output Problem	1	1
Insufficient Information	1	1
Patient Data Problem	1	1
Optical Problem	1	1
Computer Software Problem	1	1
High Readings	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Known Impact Or Consequence To Patient	215	215
No Clinical Signs, Symptoms or Conditions	80	80
No Patient Involvement	54	54
No Consequences Or Impact To Patient	54	54
Hepatitis	2	2
Reaction	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Abbott Diagnostics International, Ltd.	II	May-19-2010
2	Abbott Gmbh & Co. KG	II	Apr-17-2020
3	Abbott Gmbh & Co. KG	II	Nov-26-2019
4	Abbott Laboratories	II	Jun-06-2011
5	Roche Diagnostics Corporation	II	Jan-29-2019
6	Roche Diagnostics Operations, Inc.	II	Dec-12-2019