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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device analyzer, chemistry, centrifugal, for clinical use
Regulation Description Centrifugal chemistry analyzer for clinical use.
Product CodeJJG
Regulation Number 862.2140
Device Class 1

MDR Year MDR Reports MDR Events
2020 86 86
2021 12 12
2022 4 4
2023 5 5
2024 4 4

Device Problems MDRs with this Device Problem Events in those MDRs
Device Emits Odor 48 48
Smoking 42 42
Noise, Audible 8 8
Computer Software Problem 6 6
High Readings 5 5
Low Readings 5 5
Temperature Problem 5 5
Output Problem 4 4
Incorrect, Inadequate or Imprecise Result or Readings 4 4
No Device Output 4 4
Excessive Heating 3 3
Operating System Version or Upgrade Problem 2 2
Mechanical Jam 2 2
Low Test Results 2 2
Sparking 1 1
Device Contamination with Body Fluid 1 1
Erratic Results 1 1
Material Integrity Problem 1 1
High Test Results 1 1
Component Misassembled 1 1
Erratic or Intermittent Display 1 1
Failure to Cycle 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 78 78
No Clinical Signs, Symptoms or Conditions 30 30
Insufficient Information 4 4

Recalls
Manufacturer Recall Class Date Posted
1 Abaxis Inc II Jun-12-2020
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