Cypress, CA, United States
DiaSorin Molecular LLC recalls
5 recalls recorded since 2018, most recently on 14 June 2023. 4 are listed as ongoing. Status and classification are as published by the FDA.
Recalls5
Ongoing (FDA)4
Terminated or completed1
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 14 June 2023
- Reason
- There is a potential for the direct amplification disc to malfunction which may result in spillage of liquid from the disc.
- Distribution
- Worldwide - US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, PA, RI, SD, TN, TX, VA, VT, WA, WI, WV and the countries of Bangladesh, Canada, Israel, Italy.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2153-2023
- Simplexa Direct Amplification Disc Kit, Rx Only, IVD The Simplexa Direct Amplification Disc Kit, REF: MOL1455 is 1 box containing 3 Direct Amplification Discs (DADs). Each box contains discs individually pouch-sealed
Ongoing Class II Medical devices
- Recall started
- 30 January 2023
- Reason
- 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.
- Distribution
- US Nationwide distribution including in the states of NJ, ME, ND, IL, MI, FL, GA, AZ, MA, CA, MO, SD, MN, PA, OH, VT, NE, WI, CO, DC, VA, TX, NH, IN, IA, MD, NC, AL, NY, KY, WV, RI, KS, NM, OK, WA, SC, CT, TN, NV, LA.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1209-2023, Z-1210-2023
- Simplexa COVID-19 Direct, REF: MOL4150; including Reaction Mix, REF: MOL4150; with previous assay definition v2
- Simplexa Flu A/B & RSV Direct Gen II, REF: MOL2655; including Reaction Mix REF: MOL2656; with previous assay definition v5.
Ongoing Class II Medical devices
- Recall started
- 19 November 2021
- Reason
- 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.
- Distribution
- US: AZ, CA, CO, CT, DC, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, NC, ND, NE, NH, NJ, NM, NV, NY, OH, PA, RI, SC, SD, TN, TX, VA, VT, WA, WI, WV; and Worldwide: Kuwait, Australia, Israel, Italy, Canada, Chile, Puerto Rico, United
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0457-2022
- Simplexa Direct Amplification Disc Kit, Product Kit Code MOL1455
Ongoing Class II Medical devices
- Recall started
- 23 September 2021
- Reason
- Due to unapproved raw materials used in the manufacturing of Covid-19 control pack, their is the potential for delayed amplification signals.
- Distribution
- Worldwide distribution - US Nationwide distribution in the states of AL, AZ, CA, CO, DE, FL, GA, IL, IN, KS, KY, MA, MD, ME, MI, MN, MO, NC, ND, NE, NJ, NV, NY, OH, OK, PA, SD, TN, TX, VA, VT, WA, WI, WV and the countries of Canada, Italy.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0162-2022
- SIMPLEXA COVID-19 Positive Control Pack, REF MOL4160, IVD, Rx Only, UDI: (01) 20816101027051
Terminated Class II Medical devices
- Recall started
- 12 May 2020
- Terminated
- 19 April 2024
- Reason
- Due to a software malfunction in the Multi Assay Suite, there is the probability of increased occurrence of false negative results.
- Distribution
- Worldwide distribution - U.S. Nationwide distribution including in the states of CO, FL, KS, MI, NC, PA, TX, and WA The countries of Austria, Czech Republic, France and Switerland.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2549-2020, Z-2547-2020, Z-2548-2020
- MOL3655 Simplexa VZV Swab Direct - Product Usage: is intended for use on the LIAISON MDX instrument for the qualitative detection of varicella-zoster virus (VZV) DNA present in cutaneous and mucocutaneous lesion swabs fr
- MOL2150 Simplexa HSV 1&2 Direct -CSF -Genital Swab -Cutaneous / Mucocutaneous Swabs Product Usage: is intended for use on the LIAISON MDX instrument for the qualitative detection and differentiation of HSV-1 and HSV-2 pr
- MOL3650 Simplexa VZV Direct - Product Usage: is intended for use on the LIAISON MDX instrument for the qualitative detection of varicella-zoster virus (VZV) DNA in cerebrospinal fluid (CSF) from patients with signs and s
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.