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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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New Search show TPLC since Back to Search Results
Device system, test, thyroid autoantibody
Product CodeJZO
Regulation Number 866.5870
Device Class 2


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

MDR Year MDR Reports MDR Events
2018 35 35
2019 39 39
2020 17 17
2021 19 19
2022 25 25
2023 25 25

Device Problems MDRs with this Device Problem Events in those MDRs
High Test Results 88 88
Low Test Results 33 33
Non Reproducible Results 16 16
Incorrect, Inadequate or Imprecise Result or Readings 11 11
Adverse Event Without Identified Device or Use Problem 6 6
Incorrect Measurement 5 5
Incorrect Or Inadequate Test Results 4 4
False Negative Result 2 2
Manufacturing, Packaging or Shipping Problem 2 2
Output Problem 1 1
No Apparent Adverse Event 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 67 67
No Consequences Or Impact To Patient 66 66
No Known Impact Or Consequence To Patient 27 27

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-27-2022
5 Tosoh Bioscience Inc II Mar-08-2021
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