TPLC - Total Product Life Cycle

• Device: system, test, thyroid autoantibody
• 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
DIAGNOSTIC HYBRIDS, INC.
	SUBSTANTIALLY EQUIVALENT	2
PHADIA AB
	SUBSTANTIALLY EQUIVALENT	1
ROCHE DIAGNOSTICS
	SUBSTANTIALLY EQUIVALENT	2
SIEMENS HEALTHCARE DIAGNOSTICS, INC.
	SUBSTANTIALLY EQUIVALENT	1
THERATEST LABORATORIES, INC.
	SUBSTANTIALLY EQUIVALENT	1

MDR Year	MDR Reports	MDR Events
2014	2	2
2015	4	4
2016	8	8
2017	12	12
2018	35	35
2019	39	39
2020	17	17
2021	19	19
2022	25	25
2023	33	33
2024	19	19

Device Problems	MDRs with this Device Problem	Events in those MDRs
High Test Results	122	122
Low Test Results	41	41
Non Reproducible Results	26	26
Incorrect, Inadequate or Imprecise Result or Readings	11	11
Adverse Event Without Identified Device or Use Problem	10	10
Incorrect Or Inadequate Test Results	7	7
Incorrect Measurement	5	5
False Negative Result	2	2
Manufacturing, Packaging or Shipping Problem	2	2
False Positive Result	2	2
Device Ingredient or Reagent Problem	1	1
Output Problem	1	1
Insufficient Information	1	1
High Readings	1	1
False Reading From Device Non-Compliance	1	1
Precipitate in Device or Device Ingredient	1	1
No Apparent Adverse Event	1	1
Low Readings	1	1
Failure to Calibrate	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	94	94
No Consequences Or Impact To Patient	78	78
No Known Impact Or Consequence To Patient	41	41

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	Apr-27-2019
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
7	Tosoh Bioscience, Inc.	III	May-15-2017