TPLC - Total Product Life Cycle

• Device: radioimmunoassay, parathyroid hormone
• Regulation Description: Parathyroid hormone test system.
• Product Code: CEW
• Regulation Number: 862.1545
• Device Class: 2

Premarket Reviews
Manufacturer	Decision
BECKMAN COULTER INC
	SUBSTANTIALLY EQUIVALENT	1
ORTHO CLINICAL DIAGNOSTICS
	SUBSTANTIALLY EQUIVALENT	1
ROCHE DIAGNOSTICS
	SUBSTANTIALLY EQUIVALENT	1

MDR Year	MDR Reports	MDR Events
2020	50	50
2021	57	57
2022	188	188
2023	82	97
2024	69	69
2025	9	9

Device Problems	MDRs with this Device Problem	Events in those MDRs
Low Test Results	276	276
High Test Results	220	220
Non Reproducible Results	20	20
Incorrect Measurement	11	11
Incorrect, Inadequate or Imprecise Result or Readings	7	7
No Apparent Adverse Event	6	6
Erratic Results	5	20
Output Problem	2	2
Device Ingredient or Reagent Problem	1	1
False Negative Result	1	1
Mechanical Problem	1	1
High Readings	1	1
Adverse Event Without Identified Device or Use Problem	1	1
Unexpected Therapeutic Results	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	397	412
No Known Impact Or Consequence To Patient	30	30
No Consequences Or Impact To Patient	20	20
Insufficient Information	6	6
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	3	3
Solid Tumour	2	2
Hormonal Imbalance	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Beckman Coulter Inc.	II	Dec-11-2024
2	Beckman Coulter, Inc.	II	Jan-03-2025
3	Diasorin Inc.	II	Apr-01-2021
4	Future Diagnostics Solutions B.V.	II	Jan-25-2023
5	Ortho-Clinical Diagnostics, Inc.	II	Jan-04-2023