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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
2019 39 39
2020 17 17
2021 19 19
2022 25 25
2023 33 33
2024 6 6

Device Problems MDRs with this Device Problem Events in those MDRs
High Test Results 75 75
Low Test Results 35 35
Non Reproducible Results 17 17
Incorrect, Inadequate or Imprecise Result or Readings 11 11
Incorrect Measurement 5 5
False Negative Result 2 2
False Positive Result 2 2
Manufacturing, Packaging or Shipping Problem 2 2
Output Problem 1 1
Insufficient Information 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 81 81
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-27-2022
5 Tosoh Bioscience Inc II Mar-08-2021
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