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
1. K240252 UniCel DxH 900 Coulter Cellular Analysis System; U ...
BECKMAN COULTER, INC
	SUBSTANTIALLY EQUIVALENT	1
1. K240252 UniCel DxH 900 Coulter Cellular Analysis System; U ...
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	6

Device Problems	MDRs with this Device Problem	Events in those MDRs
Incorrect, Inadequate or Imprecise Result or Readings	639	639
Fluid/Blood Leak	198	198
Low Test Results	137	137
High Test Results	62	62
Leak/Splash	34	34
Adverse Event Without Identified Device or Use Problem	21	21
Smoking	20	20
Use of Device Problem	17	17
Device Markings/Labelling Problem	16	16
Low Readings	15	15
Thermal Decomposition of Device	13	13
Output Problem	12	12
Contamination	10	10
Unintended Electrical Shock	8	8
Improper or Incorrect Procedure or Method	8	8
Patient Data Problem	8	8
Sparking	4	4
Fire	4	4
Mechanical Problem	4	4
Missing Information	4	4
Failure to Read Input Signal	3	3
Wrong Label	3	3
Incorrect Measurement	3	3
Contamination of Device Ingredient or Reagent	3	3
Unintended Movement	2	2
High Readings	2	2
Electrical Shorting	2	2
Device Contamination with Chemical or Other Material	2	2
Intermittent Communication Failure	1	1
Arcing	1	1
False Positive Result	1	1
Electrical /Electronic Property Problem	1	1
Overheating of Device	1	1
Priming Problem	1	1
Appropriate Term/Code Not Available	1	1
Computer Software Problem	1	1
No Apparent Adverse Event	1	1
Installation-Related Problem	1	1
Retraction Problem	1	1
Sharp Edges	1	1
Missing Test Results	1	1
Blocked Connection	1	1
Obstruction of Flow	1	1
Fail-Safe Problem	1	1
Material Integrity Problem	1	1
Defective Component	1	1
Non Reproducible Results	1	1
False Negative Result	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	933	933
No Consequences Or Impact To Patient	218	218
No Patient Involvement	56	56
No Known Impact Or Consequence To Patient	48	48
Electric Shock	4	4
Needle Stick/Puncture	4	4
Eye Injury	3	3
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
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	Apr-22-2025
2	Abbott Laboratories	II	Aug-16-2024
3	Abbott Laboratories	II	Dec-21-2023
4	Beckman Coulter Inc.	II	Sep-17-2025
5	Becton, Dickinson and Company, BD Bio Sciences	II	Aug-01-2025
6	Becton, Dickinson and Company, BD Bio Sciences	II	Jul-03-2025
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