TPLC - Total Product Life Cycle

• Device: radioassay, vitamin b12
• Product Code: CDD
• Regulation Number: 862.1810
• Device Class: 2

Premarket Reviews
Manufacturer	Decision
ABBOTT LABORATORIES
	SUBSTANTIALLY EQUIVALENT	2
ANTICANCER INC
	SUBSTANTIALLY EQUIVALENT	1
AXIS-SHIELD DIAGNOSTICS LIMITED
	SUBSTANTIALLY EQUIVALENT	1
AXIS-SHIELD DIAGNOSTICS LTD.
	SUBSTANTIALLY EQUIVALENT	1
AXIS-SHIELD DIAGNOSTICS, LTD
	SUBSTANTIALLY EQUIVALENT	1
AXIS-SHIELD DIAGNOSTICS, LTD.
	SUBSTANTIALLY EQUIVALENT	2
BECKMAN COULTER BIOMEDICAL GMBH
	SUBSTANTIALLY EQUIVALENT	1
BECKMAN COULTER, INC.
	SUBSTANTIALLY EQUIVALENT	4
DIASORIN INC.
	SUBSTANTIALLY EQUIVALENT	1
DIAZYME LABORATORIES
	SUBSTANTIALLY EQUIVALENT	1
ROCHE DIAGNOSTICS
	SUBSTANTIALLY EQUIVALENT	1
SIEMENS HEALTHCARE DIAGNOSTICS
	SUBSTANTIALLY EQUIVALENT	2
SIEMENS HEALTHCARE DIAGNOSTICS INC.
	SUBSTANTIALLY EQUIVALENT	1

MDR Year	MDR Reports	MDR Events
2014	12	12
2015	4	4
2016	6	6
2017	9	9
2018	15	15
2019	14	14
2020	11	11
2021	28	28
2022	24	24
2023	28	28
2024	19	19

Device Problems	MDRs with this Device Problem	Events in those MDRs
High Test Results	68	68
Low Test Results	38	38
Non Reproducible Results	18	18
Incorrect, Inadequate or Imprecise Result or Readings	17	17
Adverse Event Without Identified Device or Use Problem	14	14
Incorrect Or Inadequate Test Results	8	8
Patient Device Interaction Problem	4	4
Device Handling Problem	4	4
No Apparent Adverse Event	4	4
Use of Device Problem	3	3
Incorrect Measurement	3	3
Appropriate Term/Code Not Available	3	3
Imprecision	2	2
Low Readings	2	2
Improper or Incorrect Procedure or Method	2	2
Mechanical Problem	1	1
Crack	1	1
Erratic Results	1	1
Unsealed Device Packaging	1	1
Material Integrity Problem	1	1
Patient Data Problem	1	1
Sharp Edges	1	1
Data Problem	1	1
Device Contamination with Chemical or Other Material	1	1
Connection Problem	1	1
False Positive Result	1	1
Fluid/Blood Leak	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	81	81
No Known Impact Or Consequence To Patient	41	41
No Consequences Or Impact To Patient	19	19
Insufficient Information	8	8
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	4	4
No Code Available	3	3
Abrasion	3	3
Injury	3	3
Test Result	2	2
Bone Fracture(s)	2	2
Head Injury	2	2
Laceration(s)	2	2
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	Ortho-Clinical Diagnostics	II	Nov-06-2018
4	Siemens Healthcare Diagnostics, Inc.	II	May-04-2018
5	Siemens Healthcare Diagnostics, Inc.	II	Jun-27-2012
6	Tosoh Bioscience Inc	II	Dec-22-2018
7	Tosoh Smd Inc	III	Dec-26-2019