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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device calibrator, primary
Product CodeJIS
Regulation Number 862.1150
Device Class 2

MDR Year MDR Reports MDR Events
2019 1 1
2020 1 1
2022 11 11
2024 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Calibration Problem 10 10
Device Ingredient or Reagent Problem 1 1
High Readings 1 1
High Test Results 1 1
Improper or Incorrect Procedure or Method 1 1
Low Test Results 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 11 11
No Known Impact Or Consequence To Patient 2 2
Hematoma 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Abbott Laboratories II Apr-07-2022
2 Fujifilm Medical Systems U.S.A., Inc. III Jan-28-2021
3 Ortho Clinical Diagnostics Inc II Feb-15-2019
4 QUIDELORTHO II May-14-2024
5 Sentinel CH SpA III Oct-06-2021
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