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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
Product CodeJJG
Regulation Number 862.2140
Device Class 1

MDR Year MDR Reports MDR Events
2018 1 1
2020 86 86
2021 12 12
2022 2 2

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 5 5
No Device Output 4 4
Incorrect, Inadequate or Imprecise Result or Readings 4 4
Low Readings 4 4
Temperature Problem 4 4
High Readings 2 2
Mechanical Jam 2 2
Excessive Heating 2 2
Output Problem 1 1
Sparking 1 1
Material Integrity Problem 1 1
Measurement System Incompatibility 1 1
Failure to Cycle 1 1
Erratic or Intermittent Display 1 1
Device Contamination with Body Fluid 1 1
High Test Results 1 1
Low Test Results 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 19 19
Insufficient Information 3 3
No Known Impact Or Consequence To Patient 1 1

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