TPLC - Total Product Life Cycle

• Device: radioassay, vitamin b12
• Regulation Description: Vitamin B12 test system.
• Product Code: CDD
• Regulation Number: 862.1810
• Device Class: 2

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

MDR Year	MDR Reports	MDR Events
2021	28	28
2022	24	24
2023	27	28
2024	33	33
2025	45	45
2026	12	12

Device Problems	MDRs with this Device Problem	Events in those MDRs
High Test Results	90	90
Low Test Results	41	42
Non Reproducible Results	29	30
Incorrect, Inadequate or Imprecise Result or Readings	20	21
Adverse Event Without Identified Device or Use Problem	5	5
Appropriate Term/Code Not Available	5	5
Patient Device Interaction Problem	4	4
Device Handling Problem	4	4
Low Readings	4	4
Erratic Results	3	3
Use of Device Problem	3	3
Output Problem	2	2
Incorrect Measurement	2	2
False Positive Result	2	2
Chemical Problem	1	1
Device Ingredient or Reagent Problem	1	1
Mechanical Problem	1	1
Crack	1	1
Unsealed Device Packaging	1	1
Material Integrity Problem	1	1
Imprecision	1	1
Sharp Edges	1	1
Calibration Problem	1	1
No Apparent Adverse Event	1	2
Improper or Incorrect Procedure or Method	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	137	138
Insufficient Information	15	15
Laceration(s)	5	5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	4	4
Bone Fracture(s)	2	2
Head Injury	2	2
Abrasion	2	2
Crushing Injury	2	2
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	Beckman Coulter, Inc.	II	Jul-11-2025