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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 1
  1.  K240469  Access TPO Antibody
BECKMAN COULTER, INC.
  SUBSTANTIALLY EQUIVALENT 1
ROCHE DIAGNOSTICS
  SUBSTANTIALLY EQUIVALENT 2
SIEMENS HEALTHCARE DIAGNOSTICS, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 17 17
2021 19 19
2022 25 25
2023 33 33
2024 29 29
2025 28 28

Device Problems MDRs with this Device Problem Events in those MDRs
High Test Results 86 86
Low Test Results 36 36
Non Reproducible Results 28 28
Incorrect, Inadequate or Imprecise Result or Readings 15 15
Incorrect Measurement 5 5
False Negative Result 2 2
Manufacturing, Packaging or Shipping Problem 2 2
Failure to Calibrate 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
No Device Output 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 132 132
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 Mckesson Medical-Surgical Inc. Corporate Office II May-27-2025
3 Roche Diagnostics Operations, Inc. II Sep-17-2020
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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