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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device apparatus, electrophoresis, for clinical use
Regulation Description Electrophoresis apparatus for clinical use.
Product CodeJJN
Regulation Number 862.2485
Device Class 1

MDR Year MDR Reports MDR Events
2016 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Device Emits Odor 1 1
Incorrect Or Inadequate Test Results 1 1
Communication or Transmission Problem 1 1
Noise, Audible 1 1

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

Recalls
Manufacturer Recall Class Date Posted
1 Perkinelmer Life Sciences, Inc. II May-22-2017
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