TPLC - Total Product Life Cycle

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Device	enzyme linked immunoabsorption assay, treponema pallidum
Product Code	LIP
Regulation Number	866.3830
Device Class	2

Premarket Reviews
Manufacturer	Decision
ABBOTT LABORATORIES
	SUBSTANTIALLY EQUIVALENT	1
BIO-RAD LABORATORIES
	SUBSTANTIALLY EQUIVALENT	1
BIO-RAD LABORATORIES, INC.
	SUBSTANTIALLY EQUIVALENT	1
DIAGNOSTICS DIRECT, LLC.
	SUBSTANTIALLY EQUIVALENT	1
FUJIREBIO DIAGNOSTICS, INC.
	SUBSTANTIALLY EQUIVALENT	1
ROCHE DIAGNOSTICS
	SUBSTANTIALLY EQUIVALENT	2
SIEMENS HEALTHCARE DIAGNOSTICS
	SUBSTANTIALLY EQUIVALENT	1
SIEMENS HEALTHCARE DIAGNOSTICS, INC.
	SUBSTANTIALLY EQUIVALENT	1
ZEUS SCIENTIFIC, INC.
	SUBSTANTIALLY EQUIVALENT	1
ZEUS SCIENTIFIC, INC. (ZEUS)
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
False Negative Result	198	198
False Positive Result	17	17
Low Test Results	14	14
Adverse Event Without Identified Device or Use Problem	3	3
No Apparent Adverse Event	3	3
Appropriate Term/Code Not Available	2	2
Off-Label Use	2	2
Incorrect, Inadequate or Imprecise Result or Readings	2	2
Unclear Information	1	1
Leak/Splash	1	1
Component Misassembled	1	1
High Test Results	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	80	80
No Known Impact Or Consequence To Patient	53	53
No Consequences Or Impact To Patient	14	14
Insufficient Information	3	3
No Code Available	2	2
Exposure to Body Fluids	1	1
Eye Injury	1	1
No Information	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Bio-Rad Laboratories	II	Jun-26-2015
2	Bio-Rad Laboratories, Inc.	II	May-16-2022
3	Bio-Rad Laboratories, Inc.	II	Mar-16-2022
4	Bio-Rad Laboratories, Inc.	II	Nov-16-2021
5	Bio-Rad Laboratories, Inc.	II	Sep-18-2020
6	Clark Laboratories, Inc. (dba,Trinity Biotech USA)	III	Dec-16-2014
7	Clark Laboratories, Inc. (dba,Trinity Biotech USA)	II	Dec-26-2013
8	Siemens Healthcare Diagnostics, Inc	II	May-24-2021
9	Siemens Healthcare Diagnostics, Inc	II	Aug-20-2012