TPLC - Total Product Life Cycle

• Device: radioimmunoassay, parathyroid hormone
• Product Code: CEW
• Regulation Number: 862.1545
• Device Class: 2

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

MDR Year	MDR Reports	MDR Events
2019	77	77
2020	50	50
2021	57	57
2022	188	188
2023	82	97
2024	65	65

Device Problems	MDRs with this Device Problem	Events in those MDRs
Low Test Results	283	283
High Test Results	257	257
Non Reproducible Results	20	20
No Apparent Adverse Event	17	17
Incorrect Measurement	12	12
Incorrect, Inadequate or Imprecise Result or Readings	8	8
Low Readings	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	386	401
No Known Impact Or Consequence To Patient	87	87
No Consequences Or Impact To Patient	37	37
Insufficient Information	5	5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	2	2
Solid Tumour	2	2
Test Result	2	2
No Patient Involvement	1	1
Hormonal Imbalance	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Diasorin Inc.	II	Apr-01-2021
2	Future Diagnostics Solutions B.V.	II	Jan-25-2023
3	Ortho-Clinical Diagnostics, Inc.	II	Jan-04-2023