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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device agglutination method, human chorionic gonadotropin
Product CodeJHJ
Regulation Number 862.1155
Device Class 2

MDR Year MDR Reports MDR Events
2014 1 1
2018 1 1
2023 4 4

Device Problems MDRs with this Device Problem Events in those MDRs
False Positive Result 4 4
Incorrect Or Inadequate Test Results 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 4 4
No Known Impact Or Consequence To Patient 1 1
No Information 1 1

Recalls
Manufacturer Recall Class Date Posted
1 PerkinElmer Life and Analytical Sciences, Wallac, OY II Apr-27-2019
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