TPLC - Total Product Life Cycle

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Premarket Reviews
Manufacturer	Decision
ABBOTT LABORATORIES
	SUBSTANTIALLY EQUIVALENT	2
AD ASTRA DIAGNOSTICS, INC.
	SUBSTANTIALLY EQUIVALENT	1
ATHELAS INC.
	SUBSTANTIALLY EQUIVALENT	1
BECKMAN COULTER
	SUBSTANTIALLY EQUIVALENT	2
	SE - WITH LIMITATIONS	1
BECKMAN COULTER, INC
	SUBSTANTIALLY EQUIVALENT	1
BECKMAN COULTER, INC.
	SUBSTANTIALLY EQUIVALENT	1
HORIBA ABX SAS
	SUBSTANTIALLY EQUIVALENT	1
NANOENTEK, INC.
	SUBSTANTIALLY EQUIVALENT	3
PIXCELL MEDICAL TECHNOLOGIES
	SUBSTANTIALLY EQUIVALENT	1
PIXCELL MEDICAL TECHNOLOGIES, LTD.
	SUBSTANTIALLY EQUIVALENT	1
S.D. SIGHT DIAGNOSTICS LTD.
	SUBSTANTIALLY EQUIVALENT	1
SIGHT DIAGNOSTICS LTD.
	SUBSTANTIALLY EQUIVALENT	1
SYSMEX AMERICA, INC.
	SUBSTANTIALLY EQUIVALENT	5

Device Problems	MDRs with this Device Problem	Events in those MDRs
Incorrect, Inadequate or Imprecise Result or Readings	1385	1385
Fluid/Blood Leak	200	200
Low Test Results	180	180
High Test Results	71	71
Leak/Splash	39	39
Adverse Event Without Identified Device or Use Problem	30	30
Use of Device Problem	30	30
Smoking	23	23
Device Markings/Labelling Problem	16	16
Low Readings	14	14
Thermal Decomposition of Device	14	14
Output Problem	13	13
Improper or Incorrect Procedure or Method	10	10
Contamination	10	10
Patient Data Problem	8	8
Unintended Electrical Shock	6	6
Fire	5	5
Sparking	5	5
Mechanical Problem	4	4
Incorrect Measurement	4	4
Missing Information	4	4
Wrong Label	3	3
Insufficient Information	3	3
Unintended Movement	3	3
High Readings	3	3
Failure to Read Input Signal	3	3
Contamination of Device Ingredient or Reagent	3	3
Device Fell	2	2
Obstruction of Flow	2	2
Overheating of Device	2	2
Appropriate Term/Code Not Available	2	2
Computer Software Problem	2	2
Device Handling Problem	2	2
Electrical Shorting	2	2
Device Contamination with Chemical or Other Material	2	2
Installation-Related Problem	2	2
Mechanical Jam	1	1
Arcing	1	1
Intermittent Communication Failure	1	1
Electrical /Electronic Property Problem	1	1
Display or Visual Feedback Problem	1	1
Priming Problem	1	1
Temperature Problem	1	1
No Apparent Adverse Event	1	1
Retraction Problem	1	1
Data Problem	1	1
Sharp Edges	1	1
Missing Test Results	1	1
Blocked Connection	1	1
Fail-Safe Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Consequences Or Impact To Patient	962	962
No Clinical Signs, Symptoms or Conditions	865	865
No Known Impact Or Consequence To Patient	125	125
No Patient Involvement	123	123
Test Result	10	10
Needle Stick/Puncture	6	6
No Code Available	5	5
Injury	5	5
Eye Injury	4	4
Misdiagnosis	3	3
Exposure to Body Fluids	3	3
Electric Shock	2	2
No Information	2	2
Unspecified Blood or Lymphatic problem	2	2
Insufficient Information	2	2
Laceration(s)	2	2
Pain	2	2
Muscle/Tendon Damage	2	2
Abdominal Pain	1	1
Fracture, Arm	1	1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1
Head Injury	1	1
Chemical Exposure	1	1
Fever	1	1
Lymphoma	1	1
Unspecified Eye / Vision Problem	1	1
Fall	1	1
Reaction	1	1
Shock	1	1
Swelling/ Edema	1	1
Thrombocytopenia	1	1
Cancer	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Abbott Laboratories	II	Aug-16-2024
2	Abbott Laboratories	II	Dec-21-2023
3	Abbott Laboratories	II	Oct-22-2019
4	Abbott Laboratories	II	Mar-29-2019
5	Beckman Coulter Inc.	I	May-23-2019
6	Beckman Coulter, Inc.	II	Nov-22-2019
7	Becton, Dickinson and Company, BD Biosciences	II	Nov-03-2022
8	Clinical Diagnostic Solutions, Inc.	II	Feb-05-2020
9	SIGHT DIAGNOSTICS LTD	II	Jun-21-2024
10	SIGHT DIAGNOSTICS LTD	II	Jul-27-2022
11	SIGHT DIAGNOSTICS LTD	II	Apr-21-2022
12	SIGHT DIAGNOSTICS LTD	II	Sep-22-2021
13	Siemens Healthcare Diagnostics, Inc.	II	Apr-09-2021