TPLC - Total Product Life Cycle

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Premarket Reviews
Manufacturer	Decision
AXIS-SHIELD DIAGNOSTICS, LTD
	SUBSTANTIALLY EQUIVALENT	1
BECKMAN COULTER BIOMEDICAL GMBH
	SUBSTANTIALLY EQUIVALENT	1
BECKMAN COULTER, INC.
	SUBSTANTIALLY EQUIVALENT	1
DIASORIN INC.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
High Test Results	59	59
Low Test Results	28	28
Non Reproducible Results	18	18
Incorrect, Inadequate or Imprecise Result or Readings	16	16
Adverse Event Without Identified Device or Use Problem	6	6
Patient Device Interaction Problem	4	4
Device Handling Problem	4	4
Use of Device Problem	3	3
Incorrect Measurement	3	3
Low Readings	3	3
Appropriate Term/Code Not Available	3	3
No Apparent Adverse Event	2	2
Mechanical Problem	1	1
Output Problem	1	1
Crack	1	1
Erratic Results	1	1
Unsealed Device Packaging	1	1
Material Integrity Problem	1	1
Imprecision	1	1
Sharp Edges	1	1
False Positive Result	1	1
Improper or Incorrect Procedure or Method	1	1
Fluid/Blood Leak	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	86	86
No Known Impact Or Consequence To Patient	11	11
Insufficient Information	8	8
No Consequences Or Impact To Patient	6	6
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	4	4
Abrasion	3	3
Injury	3	3
Bone Fracture(s)	2	2
Head Injury	2	2
Laceration(s)	2	2
No Code Available	1	1
Test Result	1	1
Concussion	1	1
Pain	1	1
Eye Injury	1	1
Muscle/Tendon Damage	1	1
Bruise/Contusion	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Beckman Coulter Biomedical GmbH	II	Sep-05-2024
2	Beckman Coulter Inc.	II	Oct-14-2021
3	Tosoh Smd Inc	III	Dec-26-2019