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DiaSorin Molecular Recalls
8 recalls on record · July 22, 2020 to July 26, 2023 · Medical Devices
Recalls by year
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Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
July 26, 2023Medical DevicesFDA
DiaSorin Molecular LLC recalls Simplexa Direct Amplification Disc Kit, Rx Only, IVD The Simplexa Direct Amplification Disc Kit, REF: MOL1455 is 1 bo
Hazard: There is a potential for the direct amplification disc to malfunction which may result in spillage of liquid from the disc.
March 15, 2023Medical DevicesFDA
DiaSorin Molecular LLC recalls Simplexa Flu A/B & RSV Direct Gen II, REF: MOL2655; including Reaction Mix REF: MOL2656; with previous assay definition
Hazard: Direct amplification Discs , used with COVID-19 and Flu A/B & RSV assays, may leak and cause contamination, cross-contamination, invalid results, and error codes.
March 15, 2023Medical DevicesFDA
DiaSorin Molecular LLC recalls Simplexa COVID-19 Direct, REF: MOL4150; including Reaction Mix, REF: MOL4150; with previous assay definition v2
Hazard: Direct amplification Discs , used with COVID-19 and Flu A/B & RSV assays, may leak and cause contamination, cross-contamination, invalid results, and error codes.
January 12, 2022Medical DevicesFDA
DiaSorin Molecular LLC recalls Simplexa Direct Amplification Disc Kit, Product Kit Code MOL1455
Hazard: A subset of affected discs are at risk of leakage when it is used more than one time with Simplexa COVID-19 Direct and/or Simplexa Flu A/B & RSV Direct Gen II. Leakage from a well that had a positive sample may cause further cross-contamination in areas of the lab if not properly cleaned.
October 27, 2021Medical DevicesFDA
DiaSorin Molecular LLC recalls SIMPLEXA COVID-19 Positive Control Pack, REF MOL4160, IVD, Rx Only, UDI: (01) 20816101027051
Hazard: Due to unapproved raw materials used in the manufacturing of Covid-19 control pack, their is the potential for delayed amplification signals.
July 22, 2020Medical DevicesFDA
DiaSorin Molecular LLC recalls MOL3655 Simplexa VZV Swab Direct - Product Usage: is intended for use on the LIAISON MDX instrument for the qualitative
Hazard: Due to a software malfunction in the Multi Assay Suite, there is the probability of increased occurrence of false negative results.
July 22, 2020Medical DevicesFDA
DiaSorin Molecular LLC recalls MOL3650 Simplexa VZV Direct - Product Usage: is intended for use on the LIAISON MDX instrument for the qualitative detec
Hazard: Due to a software malfunction in the Multi Assay Suite, there is the probability of increased occurrence of false negative results.
July 22, 2020Medical DevicesFDA
DiaSorin Molecular LLC recalls MOL2150 Simplexa HSV 1&2 Direct -CSF -Genital Swab -Cutaneous / Mucocutaneous Swabs Product Usage: is intended for use o
Hazard: Due to a software malfunction in the Multi Assay Suite, there is the probability of increased occurrence of false negative results.