DiaSorin Molecular recalls
4 official recalls and safety alerts involving DiaSorin Molecular since 2021-10, from FDA · Device. Newest first. Check the official notice for exact models and batch codes.
This list only includes recalls Recall Atlas has collected since 2021-10. A product not listed here may still be affected; check with DiaSorin Molecular or the relevant agency.
- 2023-07-26
USDiaSorin Molecular LLC recalls Simplexa Direct Amplification Disc Kit, Rx Only, IVD The Simplexa Direct Amplification Disc Kit, REF: MOL1455 is 1 box containing 3 Direct…
There is a potential for the direct amplification disc to malfunction which may result in spillage of liquid from the disc.
FDA · DeviceDiaSorin Molecular LLCWorldwide - US Nationwide distribution including in the states of AL, AR, AZ,…Official notice →- 2023-03-15
- US
DiaSorin Molecular LLC recalls Simplexa COVID-19 Direct, REF: MOL4150; including Reaction Mix, REF: MOL4150; with previous assay definition v2
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.
FDA · DeviceDiaSorin Molecular LLCUS Nationwide distribution including in the states of NJ, ME, ND, IL, MI, FL,…Official notice → - 2022-01-12
- US
DiaSorin Molecular LLC recalls Simplexa Direct Amplification Disc Kit, Product Kit Code MOL1455
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…
FDA · DeviceDiaSorin Molecular LLCUS: AZ, CA, CO, CT, DC, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI,…Official notice → - 2021-10-27
- US
DiaSorin Molecular LLC recalls SIMPLEXA COVID-19 Positive Control Pack, REF MOL4160, IVD, Rx Only, UDI: (01) 20816101027051
Due to unapproved raw materials used in the manufacturing of Covid-19 control pack, their is the potential for delayed amplification signals.
FDA · DeviceDiaSorin Molecular LLCWorldwide distribution - US Nationwide distribution in the states of AL, AZ,…Official notice →