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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device system, test, thyroid autoantibody
Regulation Description Thyroid autoantibody immunological test system.
Product CodeJZO
Regulation Number 866.5870
Device Class 2


Premarket Reviews
ManufacturerDecision
BECKMAN COULTER, INC.
  SUBSTANTIALLY EQUIVALENT 2
ROCHE DIAGNOSTICS
  SUBSTANTIALLY EQUIVALENT 1
SIEMENS HEALTHCARE DIAGNOSTICS, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2021 19 19
2022 25 26
2023 33 33
2024 29 29
2025 45 45

Device Problems MDRs with this Device Problem Events in those MDRs
High Test Results 85 86
Low Test Results 33 33
Non Reproducible Results 30 30
Incorrect, Inadequate or Imprecise Result or Readings 29 29
Incorrect Measurement 5 6
False Negative Result 2 2
Output Problem 2 2
Manufacturing, Packaging or Shipping Problem 2 2
Failure to Calibrate 2 2
False Positive Result 2 2
Insufficient Information 1 1
High Readings 1 1
Precipitate in Device or Device Ingredient 1 1
Low Readings 1 1
No Apparent Adverse Event 1 1
No Device Output 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 147 148
No Consequences Or Impact To Patient 2 2

Recalls
Manufacturer Recall Class Date Posted
1 Abbott Ireland Limited III Jun-08-2023
2 Mckesson Medical-Surgical Inc. Corporate Office II May-27-2025
3 Roche Diagnostics Operations, Inc. II Jan-02-2026
4 Siemens Healthcare Diagnostics, Inc. II Sep-27-2024
5 Siemens Healthcare Diagnostics, Inc. II May-23-2024
6 Siemens Healthcare Diagnostics, Inc. II Sep-27-2022
7 Tosoh Bioscience Inc II Mar-08-2021
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