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, INC.
	SUBSTANTIALLY EQUIVALENT	2
CYTOCHIP, INC.
	SUBSTANTIALLY EQUIVALENT	1
HORIBA ABX SAS
	SUBSTANTIALLY EQUIVALENT	1
NANOENTEK, INC.
	SUBSTANTIALLY EQUIVALENT	1
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
TRUVIAN SCIENCES, INC.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Incorrect, Inadequate or Imprecise Result or Readings	423	428
Fluid/Blood Leak	151	151
Low Test Results	130	157
High Test Results	53	55
Leak/Splash	29	30
Device Markings/Labelling Problem	15	15
Adverse Event Without Identified Device or Use Problem	15	16
Smoking	13	14
Low Readings	11	11
Contamination	10	10
Use of Device Problem	9	9
Improper or Incorrect Procedure or Method	8	8
Output Problem	8	8
Patient Data Problem	7	8
Thermal Decomposition of Device	6	7
Sparking	5	5
Unintended Electrical Shock	5	5
Missing Information	4	4
Mechanical Problem	4	4
Fire	4	4
Wrong Label	3	3
Contamination of Device Ingredient or Reagent	3	3
High Readings	2	2
Unintended Movement	2	2
Incorrect Measurement	2	2
Electrical Shorting	2	2
Computer Software Problem	2	2
Failure to Read Input Signal	2	2
Fail-Safe Problem	1	1
Material Integrity Problem	1	1
Obstruction of Flow	1	1
Blocked Connection	1	1
Missing Test Results	1	1
Sharp Edges	1	1
Non Reproducible Results	1	1
Break	1	1
Retraction Problem	1	1
Installation-Related Problem	1	2
No Apparent Adverse Event	1	1
Appropriate Term/Code Not Available	1	1
Priming Problem	1	1
Overheating of Device	1	1
False Positive Result	1	1
Arcing	1	1
Device Remains Activated	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	891	930
No Consequences Or Impact To Patient	13	13
Needle Stick/Puncture	5	5
No Patient Involvement	5	5
Insufficient Information	4	4
Electric Shock	3	3
Unspecified Blood or Lymphatic problem	2	2
Exposure to Body Fluids	2	2
Laceration(s)	2	3
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
Eye Burn	1	1
No Known Impact Or Consequence To Patient	1	1
Fever	1	1
Burning Sensation	1	1
Lymphoma	1	1
Unspecified Eye / Vision Problem	1	1
Fall	1	1
Swelling/ Edema	1	1
Blurred Vision	1	1
Thrombocytopenia	1	1
Cancer	1	1
Skin Burning Sensation	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Abbott Laboratories	II	Nov-12-2025
2	Abbott Laboratories	II	Apr-22-2025
3	Abbott Laboratories	II	Aug-16-2024
4	Abbott Laboratories	II	Dec-21-2023
5	Beckman Coulter Inc.	II	Sep-17-2025
6	Becton, Dickinson and Company, BD Bio Sciences	II	Aug-01-2025
7	Becton, Dickinson and Company, BD Bio Sciences	II	Jul-03-2025
8	Becton, Dickinson and Company, BD Biosciences	II	Nov-03-2022
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