TPLC - Total Product Life Cycle

• Device: kit, quality control for blood banking reagents
• Product Code: KSF
• Regulation Number: 864.9650
• Device Class: 2

Premarket Reviews
Manufacturer	Decision
ALBA BIOSCIENCE LIMITED
	SUBSTANTIALLY EQUIVALENT	4
ALBA BIOSCIENCE LIMITED (DOING BUSINESS AS QUOTIENT)
	SUBSTANTIALLY EQUIVALENT	4
AMERICAN RED CROSS
	SUBSTANTIALLY EQUIVALENT	2
BIO-RAD MEDICAL DIAGNOSTICS GMBH
	SUBSTANTIALLY EQUIVALENT	3
DIAGAST
	SUBSTANTIALLY EQUIVALENT	2
HEMO BIOSCIENCE
	SUBSTANTIALLY EQUIVALENT	4
IMMUCOR, INC.
	SUBSTANTIALLY EQUIVALENT	2
MEDION GRIFOLS DIAGNOSTICS AG
	SUBSTANTIALLY EQUIVALENT	2
MICRO TYPING SYSTEMS INC.
	SUBSTANTIALLY EQUIVALENT	1
MILLIPORE (UK) LTD
	SUBSTANTIALLY EQUIVALENT	1

MDR Year	MDR Reports	MDR Events
2015	4	4
2016	16	16
2017	19	19
2018	20	20
2019	10	10
2020	1	1
2022	1	1
2023	2	2
2024	2	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
False Negative Result	61	61
False Positive Result	3	3
Nonstandard Device	2	2
Off-Label Use	2	2
Incorrect, Inadequate or Imprecise Result or Readings	2	2
Defective Device	2	2
Chemical Spillage	1	1
Human Factors Issue	1	1
No Apparent Adverse Event	1	1
Insufficient Information	1	1
Short Fill	1	1
Incorrect Or Inadequate Test Results	1	1
Fluid/Blood Leak	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Known Impact Or Consequence To Patient	36	36
No Consequences Or Impact To Patient	28	28
No Clinical Signs, Symptoms or Conditions	3	3
No Code Available	2	2
Chemical Exposure	2	2
Patient Problem/Medical Problem	1	1
No Information	1	1
Unspecified Eye / Vision Problem	1	1
Fever	1	1