TPLC - Total Product Life Cycle

show TPLC since

Device	system, test, automated, antimicrobial susceptibility, short incubation
Product Code	LON
Regulation Number	866.1645
Device Class	2

Premarket Reviews
Manufacturer	Decision
BECKMAN COULTER INC.
	SUBSTANTIALLY EQUIVALENT	1
BECTON, DICKINSON & CO.
	SUBSTANTIALLY EQUIVALENT	3
BECTON, DICKINSON & COMPANY
	SUBSTANTIALLY EQUIVALENT	1
BECTON, DICKINSON AND COMPANY
	SUBSTANTIALLY EQUIVALENT	9
BECTON, DICKINSON, AND COMPANY
	SUBSTANTIALLY EQUIVALENT	1
BECTON,DICKINSON AND COMPANY
	SUBSTANTIALLY EQUIVALENT	1
BIOMERIEUX SA, INC.
	SUBSTANTIALLY EQUIVALENT	1
BIOMERIEUX, INC
	SUBSTANTIALLY EQUIVALENT	21
BIOMÉRIEUX, INC
	SUBSTANTIALLY EQUIVALENT	1
BIOMERIEUX, INC.
	SUBSTANTIALLY EQUIVALENT	50
COPAN WASP S.R.L.
	SUBSTANTIALLY EQUIVALENT	2
SELUX DIAGNOSTICS, INC
	SUBSTANTIALLY EQUIVALENT	1
SELUX DIAGNOSTICS, INC.
	SUBSTANTIALLY EQUIVALENT	1
SIEMENS HEALTHCARE DIAGNOSTICS
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Incorrect, Inadequate or Imprecise Result or Readings	1866	1869
Incorrect Or Inadequate Test Results	209	209
False Positive Result	208	208
False Negative Result	21	21
Mechanical Problem	21	21
Computer Software Problem	20	20
Contamination	18	18
Low Test Results	17	17
Device Markings/Labelling Problem	13	13
Missing Test Results	13	13
Contamination of Device Ingredient or Reagent	11	11
Use of Device Problem	11	11
Improper or Incorrect Procedure or Method	10	10
Incorrect Measurement	9	9
Output Problem	7	7
Communication or Transmission Problem	5	5
Device Operates Differently Than Expected	4	4
Device Contamination with Chemical or Other Material	4	4
Smoking	4	4
Adverse Event Without Identified Device or Use Problem	4	4
Failure to Back-Up	4	4
Patient Data Problem	4	4
Loss of Data	3	3
Electrical /Electronic Property Problem	3	3
Data Back-Up Problem	3	3
Product Quality Problem	3	3
Unable to Obtain Readings	3	3
Microbial Contamination of Device	3	3
Therapeutic or Diagnostic Output Failure	3	3
Device Damaged Prior to Use	3	3
Leak/Splash	3	3
Failure to Obtain Sample	2	2
Expiration Date Error	2	2
High Test Results	2	2
Insufficient Information	2	2
Application Program Problem	2	2
Fire	2	2
Device Ingredient or Reagent Problem	2	2
No Device Output	2	2
High Readings	1	1
Difficult to Insert	1	1
Battery Problem	1	1
Device Packaging Compromised	1	1
Incorrect Device Or Component Shipped	1	1
Physical Resistance	1	1
Unsealed Device Packaging	1	1
Packaging Problem	1	1
Data Problem	1	1
Program or Algorithm Execution Failure	1	1
Decreased Sensitivity	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	1078	1078
No Known Impact Or Consequence To Patient	775	775
No Consequences Or Impact To Patient	455	458
No Patient Involvement	135	135
Misdiagnosis	44	44
Insufficient Information	18	18
Death	4	4
Test Result	4	4
Bacterial Infection	3	3
Drug Resistant Bacterial Infection	2	2
Not Applicable	2	2
No Information	2	2
Unspecified Infection	1	1
Sepsis	1	1
No Code Available	1	1
Inflammation	1	1
Chemical Exposure	1	1
Localized Skin Lesion	1	1
Injury	1	1
Needle Stick/Puncture	1	1
Diarrhea	1	1
Laceration(s)	1	1
Toxic Shock Syndrome	1	1
Therapeutic Response, Decreased	1	1
Therapeutic Effects, Unexpected	1	1
Premature Labor	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Becton Dickinson & Co.	II	Mar-29-2024
2	Becton Dickinson & Co.	II	Nov-14-2022
3	Becton Dickinson & Co.	II	Dec-31-2020
4	Becton Dickinson & Co.	II	Feb-23-2019
5	Becton Dickinson & Co.	II	Nov-25-2017
6	Becton Dickinson & Co.	III	Oct-25-2016
7	Becton Dickinson & Co.	II	Dec-19-2012
8	Becton Dickinson & Co.	II	May-24-2012
9	Becton Dickinson & Co.	II	Mar-30-2011
10	Becton Dickinson & Co.	II	Nov-15-2010
11	BioMerieux SA	II	Jun-12-2018
12	Biomerieux Inc	I	Apr-25-2024
13	Biomerieux Inc	II	Jan-04-2023
14	Biomerieux Inc	II	Mar-25-2021
15	Biomerieux Inc	II	Aug-25-2017
16	Biomerieux Inc	II	May-22-2017
17	Biomerieux Inc	II	May-03-2016
18	Biomerieux Inc	I	Apr-27-2011
19	Biomerieux Inc	I	Nov-11-2010
20	Biomerieux Inc	II	Aug-27-2010
21	Organon Teknika Inc	II	Feb-27-2019
22	Remel Inc.	II	May-08-2020
23	Siemens Healthcare Diagnostics, Inc.	I	Nov-07-2014
24	Siemens Healthcare Diagnostics, Inc.	I	Sep-11-2013
25	Siemens Microscan	II	Feb-04-2009
26	bioMerieux, Inc.	II	May-11-2022
27	bioMerieux, Inc.	II	Apr-12-2019
28	bioMerieux, Inc.	II	Feb-16-2019
29	bioMerieux, Inc.	II	Dec-19-2018
30	bioMerieux, Inc.	II	Dec-17-2018
31	bioMerieux, Inc.	I	Aug-30-2018