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	17	17

Device Problems	MDRs with this Device Problem	Events in those MDRs
Low Test Results	288	289
High Test Results	207	207
Non Reproducible Results	34	34
Incorrect Measurement	12	12
Imprecise or Erratic Results	5	20
Incorrect, Inadequate or Imprecise Result or Readings	5	6
No Apparent Adverse Event	4	4
Prophylactic removal due to corrective action	2	2
False Negative Result	2	2
Mechanical Problem	2	2
Output Problem	1	1
Appropriate Device Problem Term/Code Not Available	1	1
Unable to Obtain Readings	1	1
Device Ingredient or Reagent Problem	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	433	449
Insufficient Information	8	8
No Consequences Or Impact To Patient	3	3
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available	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