Home / Recalls / DiaSorin Molecular LLC / Z-0162-2022

Z-0162-2022 Class II Ongoing

Recalled by DiaSorin Molecular LLC — Cypress, CA

Recall Details

Product Type
Devices
Report Date
October 27, 2021
Initiation Date
September 23, 2021
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1690 kits

Product Description

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

Reason for Recall

Due to unapproved raw materials used in the manufacturing of Covid-19 control pack, their is the potential for delayed amplification signals.

Distribution Pattern

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.

Code Information

Lot #/Expiration Date: 12175N/11.30.2021, 12722N/01.31.2022, X12122N/01.31.2022, X12724N/08.31.2022

Other recalls by DiaSorin Molecular LLC

  • Z-2153-2023 Class II — Simplexa Direct Amplification Disc Kit, Rx Only, IVD The Simplexa Direct Ampl (June 14, 2023)
  • Z-1209-2023 Class II — Simplexa COVID-19 Direct, REF: MOL4150; including Reaction Mix, REF: MOL4150; wi (January 30, 2023)
  • Z-1210-2023 Class II — Simplexa Flu A/B & RSV Direct Gen II, REF: MOL2655; including Reaction Mix REF: (January 30, 2023)
  • Z-0457-2022 Class II — Simplexa Direct Amplification Disc Kit, Product Kit Code MOL1455 (November 19, 2021)
  • Z-2547-2020 Class II — MOL2150 Simplexa HSV 1&2 Direct -CSF -Genital Swab -Cutaneous / Mucocutaneous Sw (May 12, 2020)
  • Z-2549-2020 Class II — MOL3655 Simplexa VZV Swab Direct - Product Usage: is intended for use on the LIA (May 12, 2020)
  • Z-2548-2020 Class II — MOL3650 Simplexa VZV Direct - Product Usage: is intended for use on the LIAISON (May 12, 2020)