TPLC - Total Product Life Cycle

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Device	counter, differential cell
Regulation Description	Automated differential cell counter.
Product Code	GKZ
Regulation Number	864.5220
Device Class	2

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	1
BECKMAN COULTER, INC
	SUBSTANTIALLY EQUIVALENT	1
BECKMAN COULTER, INC.
	SUBSTANTIALLY EQUIVALENT	1
CYTOCHIP INC.
	SUBSTANTIALLY EQUIVALENT	1
HORIBA ABX SAS
	SUBSTANTIALLY EQUIVALENT	1
NANOENTEK, INC.
	SUBSTANTIALLY EQUIVALENT	2
PIXCELL MEDICAL TECHNOLOGIES
	SUBSTANTIALLY EQUIVALENT	1
PIXCELL MEDICAL TECHNOLOGIES, LTD.
	SUBSTANTIALLY EQUIVALENT	1
S.D. SIGHT DIAGNOSTICS LTD.
	SUBSTANTIALLY EQUIVALENT	1
SYSMEX AMERICA, INC.
	SUBSTANTIALLY EQUIVALENT	4

Device Problems	MDRs with this Device Problem	Events in those MDRs
Incorrect, Inadequate or Imprecise Result or Readings	629	629
Fluid/Blood Leak	198	198
Low Test Results	115	115
High Test Results	50	50
Leak/Splash	32	32
Smoking	20	20
Adverse Event Without Identified Device or Use Problem	20	20
Use of Device Problem	17	17
Device Markings/Labelling Problem	16	16
Low Readings	14	14
Thermal Decomposition of Device	13	13
Contamination	10	10
Improper or Incorrect Procedure or Method	8	8
Output Problem	8	8
Patient Data Problem	8	8
Unintended Electrical Shock	6	6
Fire	4	4
Mechanical Problem	4	4
Missing Information	4	4
Failure to Read Input Signal	3	3
Sparking	3	3
Wrong Label	3	3
Contamination of Device Ingredient or Reagent	3	3
Incorrect Measurement	3	3
Device Contamination with Chemical or Other Material	2	2
Electrical Shorting	2	2
High Readings	2	2
Unintended Movement	2	2
Blocked Connection	1	1
Missing Test Results	1	1
Sharp Edges	1	1
Obstruction of Flow	1	1
Fail-Safe Problem	1	1
Retraction Problem	1	1
Material Integrity Problem	1	1
Defective Component	1	1
Installation-Related Problem	1	1
No Apparent Adverse Event	1	1
Non Reproducible Results	1	1
Computer Software Problem	1	1
Appropriate Term/Code Not Available	1	1
Priming Problem	1	1
Overheating of Device	1	1
Electrical /Electronic Property Problem	1	1
False Negative Result	1	1
Arcing	1	1
Intermittent Communication Failure	1	1
Break	1	1
Device Remains Activated	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	881	881
No Consequences Or Impact To Patient	218	218
No Patient Involvement	56	56
No Known Impact Or Consequence To Patient	48	48
Needle Stick/Puncture	3	3
Electric Shock	2	2
Misdiagnosis	2	2
Test Result	2	2
Unspecified Blood or Lymphatic problem	2	2
Injury	2	2
Exposure to Body Fluids	2	2
Insufficient Information	2	2
Laceration(s)	2	2
Pain	2	2
Eye Injury	2	2
Muscle/Tendon Damage	2	2
Abdominal Pain	1	1
Superficial (First Degree) Burn	1	1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1
No Code Available	1	1
No Information	1	1
Eye Burn	1	1
Chemical Exposure	1	1
Fever	1	1
Lymphoma	1	1
Unspecified Eye / Vision Problem	1	1
Fall	1	1
Shock	1	1
Swelling/ Edema	1	1
Thrombocytopenia	1	1
Cancer	1	1
Skin Burning Sensation	1	1

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