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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device multi-analyte controls unassayed
Definition A quality control material (unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (unassayed) for blood gases, electrolytes, enzymes, multianalytes, single (specified) analytes, or urinalysis controls.
Product CodeOHQ
Regulation Number 862.1660
Device Class 1

MDR Year MDR Reports MDR Events
2022 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
No Device Output 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 2 2

Recalls
Manufacturer Recall Class Date Posted
1 Biomerieux Inc II Jan-04-2023
2 Microbiologics Inc II Feb-12-2024
3 Microbiologics Inc III Sep-14-2022
4 Microbiologics Inc II Apr-19-2022
5 Microbiologics Inc II Apr-19-2022
6 Microbiologics Inc II Mar-31-2022
7 Microbiologics Inc II Mar-14-2022
8 Microbiologics Inc II Mar-01-2022
9 Microbiologics Inc II Sep-17-2021
10 Microbiologics Inc II Sep-17-2021
11 Microbiologics Inc II Feb-05-2020
12 Microbiologics Inc II Jan-16-2020
13 Randox Laboratories Ltd. III Jan-02-2024
14 Randox Laboratories Ltd. II Sep-19-2022
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