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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
Regulation Description Quality control material (assayed and 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 Mar-25-2025
3 Microbiologics Inc II Mar-14-2025
4 Microbiologics Inc II Feb-12-2025
5 Microbiologics Inc II Feb-12-2024
6 Microbiologics Inc III Sep-14-2022
7 Microbiologics Inc II Apr-19-2022
8 Microbiologics Inc II Apr-19-2022
9 Microbiologics Inc II Mar-31-2022
10 Microbiologics Inc II Mar-14-2022
11 Microbiologics Inc II Mar-01-2022
12 Microbiologics Inc II Sep-17-2021
13 Microbiologics Inc II Sep-17-2021
14 Microbiologics Inc II Feb-05-2020
15 Microbiologics Inc II Jan-16-2020
16 Randox Laboratories Ltd. III Jan-02-2024
17 Randox Laboratories Ltd. II Sep-19-2022
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