DiaSorin Molecular LLC recalls

8 recalls on record · latest: June 14, 2023

Official U.S. recall history for DiaSorin Molecular LLC, compiled from official government records.

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DiaSorin Molecular LLC recalls Simplexa Direct Amplification Disc Kit, Rx Only, IVD The Simplexa Direct Amplification Disc Kit, REF: MOL1455 is 1 box…

June 14, 2023 · Medical device recalls Moderate risk There is a potential for the direct amplification disc to malfunction which may…

DiaSorin Molecular LLC recalls Simplexa COVID-19 Direct, REF: MOL4150; including Reaction Mix, REF: MOL4150; with previous assay definition v2

January 30, 2023 · Medical device recalls Moderate risk Direct amplification Discs , used with COVID-19 and Flu A/B & RSV assays, may l…

DiaSorin Molecular LLC recalls Simplexa Flu A/B & RSV Direct Gen II, REF: MOL2655; including Reaction Mix REF: MOL2656; with previous assay definition…

January 30, 2023 · Medical device recalls Moderate risk Direct amplification Discs , used with COVID-19 and Flu A/B & RSV assays, may l…

DiaSorin Molecular LLC recalls Simplexa Direct Amplification Disc Kit, Product Kit Code MOL1455

November 19, 2021 · Medical device recalls Moderate risk A subset of affected discs are at risk of leakage when it is used more than one…

DiaSorin Molecular LLC recalls SIMPLEXA COVID-19 Positive Control Pack, REF MOL4160, IVD, Rx Only, UDI: (01) 20816101027051

September 23, 2021 · Medical device recalls Moderate risk Due to unapproved raw materials used in the manufacturing of Covid-19 control p…

DiaSorin Molecular LLC recalls MOL3655 Simplexa VZV Swab Direct - Product Usage: is intended for use on the LIAISON MDX instrument for the qualitative…

May 12, 2020 · Medical device recalls Moderate risk Due to a software malfunction in the Multi Assay Suite, there is the probabilit…

DiaSorin Molecular LLC recalls MOL2150 Simplexa HSV 1&2 Direct -CSF -Genital Swab -Cutaneous / Mucocutaneous Swabs Product Usage: is intended for use…

May 12, 2020 · Medical device recalls Moderate risk Due to a software malfunction in the Multi Assay Suite, there is the probabilit…

DiaSorin Molecular LLC recalls MOL3650 Simplexa VZV Direct - Product Usage: is intended for use on the LIAISON MDX instrument for the qualitative dete…

May 12, 2020 · Medical device recalls Moderate risk Due to a software malfunction in the Multi Assay Suite, there is the probabilit…