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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device enzyme linked immunoabsorbent assay, mumps virus
Product CodeLJY
Regulation Number 866.3380
Device Class 1

MDR Year MDR Reports MDR Events
2016 5 5
2018 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect, Inadequate or Imprecise Result or Readings 4 4
Device Displays Incorrect Message 1 1
Battery Problem 1 1
Connection Problem 1 1
Break 1 1
Disconnection 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 5 5
No Patient Involvement 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Bion Enterprises Ltd III Jun-05-2013
2 Calbiotech Inc II Mar-05-2010
3 Diamedix Corporation III Jul-28-2018
4 Diamedix Corporation II May-16-2016
5 Zeus Scientific, Inc. III May-08-2012
6 bioMerieux, Inc. II Dec-28-2021
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