Home / Recalls / DiaSorin Molecular LLC / Z-1209-2023

Z-1209-2023 Class II Ongoing

Recalled by DiaSorin Molecular LLC — Cypress, CA

FDA device recall Z-1209-2023 was initiated by DiaSorin Molecular LLC on January 30, 2023 and is designated Class II. Reason for recall: 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. The recall status is ongoing. Affected quantity: 90142.

Recall Details

Product Type
Devices
Report Date
March 15, 2023
Initiation Date
January 30, 2023
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
90142

Product Description

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

Reason for Recall

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 Pattern

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.

Code Information

UDI-DI: 20816101027020. Product REF/Lot/Reaction Mix REF/Lot: MOL4150/US13950/MOL4151/US14091, MOL4150/US14913/MOL4151/US14063, MOL4150/US13952/MOL4151/US14065, MOL4150/US13955/MOL4151/US14086, MOL4150/US13959/MOL4151/US14088, MOL4150/US13956/MOL4151/US14087, MOL4150/US13960/MOL4151/US14093, MOL4150/US13961/MOL4151/US14094, MOL4150/US13973/MOL4151/US13732, MOL4150/US13974/MOL4151/US13736, MOL4150/US14006/MOL4151/US13738, MOL4150/US14004/MOL4151/US15064, MOL4150/US14005/MOL4151/US13737, MOL4150/US14008/MOL4151/US14100, MOL4150/US14007/MOL4151/US14099, MOL4150/US14010/MOL4151/US14102, MOL4150/US14011/MOL4151/US14103, MOL4150/US14012/MOL4151/US15290, MOL4150/US14018/MOL4151/US14111, MOL4150/US14009/MOL4151/US14101, MOL4150/US14017/MOL4151/US14109, MOL4150/15061N/MOL4151/13474N, MOL4150/X15475N/MOL4151/X15479N, MOL4150/13330N/MOL4151/14829N, MOL4150/13331N/MOL4151/13751N, MOL4150/13336N/MOL4151/13752N, MOL4150/13968N/MOL4151/14036N, MOL4150/14346N/MOL4151/14038N, MOL4150/13967N/MOL4151/15082N

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-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-0162-2022 Class II — SIMPLEXA COVID-19 Positive Control Pack, REF MOL4160, IVD, Rx Only, UDI: (01) 20 (September 23, 2021)
  • Z-2547-2020 Class II — MOL2150 Simplexa HSV 1&2 Direct -CSF -Genital Swab -Cutaneous / Mucocutaneous Sw (May 12, 2020)
  • Z-2548-2020 Class II — MOL3650 Simplexa VZV Direct - Product Usage: is intended for use on the LIAISON (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)

FDA data resources