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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
Product CodeJZO
Regulation Number 866.5870
Device Class 2


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

MDR Year MDR Reports MDR Events
2019 39 39
2020 17 17
2021 19 19
2022 25 25
2023 33 33
2024 25 25

Device Problems MDRs with this Device Problem Events in those MDRs
High Test Results 92 92
Low Test Results 37 37
Non Reproducible Results 24 24
Incorrect, Inadequate or Imprecise Result or Readings 12 12
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

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 100 100
No Consequences Or Impact To Patient 44 44
No Known Impact Or Consequence To Patient 14 14

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 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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