TPLC - Total Product Life Cycle

• Device: system, test, thyroid autoantibody
• Regulation Description: Thyroid autoantibody immunological test system.
• Product Code: JZO
• Regulation Number: 866.5870
• Device Class: 2

Premarket Reviews
Manufacturer	Decision
BECKMAN COULTER INC.
	SUBSTANTIALLY EQUIVALENT	1
BECKMAN COULTER, INC.
	SUBSTANTIALLY EQUIVALENT	1
ROCHE DIAGNOSTICS
	SUBSTANTIALLY EQUIVALENT	2

MDR Year	MDR Reports	MDR Events
2020	17	17
2021	19	19
2022	25	25
2023	33	33
2024	30	30
2025	10	10

Device Problems	MDRs with this Device Problem	Events in those MDRs
High Test Results	74	74
Low Test Results	33	33
Non Reproducible Results	24	24
Incorrect, Inadequate or Imprecise Result or Readings	13	13
Incorrect Measurement	5	5
False Negative Result	2	2
Manufacturing, Packaging or Shipping Problem	2	2
False Positive Result	2	2
Output Problem	1	1
Insufficient Information	1	1
High Readings	1	1
Precipitate in Device or Device Ingredient	1	1
Low Readings	1	1
Failure to Calibrate	1	1
No Device Output	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	115	115
No Consequences Or Impact To Patient	14	14
No Known Impact Or Consequence To Patient	5	5

Recalls
Manufacturer		Recall Class	Date Posted
1	Abbott Ireland Limited	III	Jun-08-2023
2	Roche Diagnostics Operations, Inc.	II	Sep-17-2020
3	Siemens Healthcare Diagnostics, Inc.	II	Sep-27-2024
4	Siemens Healthcare Diagnostics, Inc.	II	May-23-2024
5	Siemens Healthcare Diagnostics, Inc.	II	Sep-27-2022
6	Tosoh Bioscience Inc	II	Mar-08-2021