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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 kit, test,alpha-fetoprotein for testicular cancer
Regulation Description Tumor-associated antigen immunological test system.
Product CodeLOJ
Regulation Number 866.6010
Device Class 2

MDR Year MDR Reports MDR Events
2016 5 5
2017 9 9
2018 17 17
2019 14 14
2020 1 1
2021 5 5

Device Problems MDRs with this Device Problem Events in those MDRs
No Apparent Adverse Event 18 18
Adverse Event Without Identified Device or Use Problem 12 12
High Test Results 9 9
Low Test Results 7 7
Off-Label Use 4 4
Incorrect, Inadequate or Imprecise Resultor Readings 2 2
Incorrect Or Inadequate Test Results 2 2
Non Reproducible Results 2 2
False Positive Result 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 30 30
No Consequences Or Impact To Patient 13 13
No Clinical Signs, Symptoms or Conditions 4 4
No Code Available 2 2
No Information 1 1
Insufficient Information 1 1

Recalls
Manufacturer Recall Class Date Posted
1 ORTHO-CLINICAL DIAGNOSTICS III Jul-08-2016
2 Tosoh Bioscience Inc II Jun-05-2018
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