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
1.  K232791  Access Intact PTH
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	17	17

Device Problems	MDRs with this Device Problem	Events in those MDRs
Low Test Results	289	290
High Test Results	208	208
Non Reproducible Results	35	35
Incorrect Measurement	12	12
Incorrect, Inadequate or Imprecise Result or Readings	5	6
Imprecise or Erratic Results	5	20
No Apparent Adverse Event	4	4
False Negative Result	2	2
Mechanical Problem	2	2
Prophylactic removal due to corrective action	2	2
Device Ingredient or Reagent Problem	1	1
Output Problem	1	1
Unable to Obtain Readings	1	1
Adverse Event Without Identified Device or Use Problem	1	1
Appropriate Device Problem Term/Code Not Available	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	433	449
Insufficient Information	8	8
No Known Impact Or Consequence To Patient	3	3
No Consequences Or Impact To Patient	3	3
Appropriate Clinical Signs, Symptoms and 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
6	Siemens Healthcare Diagnostics, Inc.	II	Oct-27-2025