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
2021	57	57
2022	188	188
2023	82	97
2024	67	68
2025	38	38
2026	3	3

Device Problems	MDRs with this Device Problem	Events in those MDRs
Low Test Results	283	284
High Test Results	203	203
Non Reproducible Results	29	29
Incorrect Measurement	11	11
Erratic Results	5	20
Incorrect, Inadequate or Imprecise Result or Readings	5	6
No Apparent Adverse Event	4	4
False Negative Result	2	2
Device Ingredient or Reagent Problem	1	1
Mechanical Problem	1	1
Output Problem	1	1
Unable to Obtain Readings	1	1
Adverse Event Without Identified Device or Use Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	420	436
Insufficient Information	7	7
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	3	3
No Consequences Or Impact To Patient	3	3
No Known Impact Or Consequence To Patient	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
6	Siemens Healthcare Diagnostics, Inc.	II	Oct-27-2025