DiaSorin Molecular LLC: Medical Device Recall in 2023 - (Recall #: Z-1210-2023)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2023.

Data Source: FDA.

Product Description:

Simplexa Flu A/B & RSV Direct Gen II, REF: MOL2655; including Reaction Mix REF: MOL2656; with previous assay definition v5.

Product Classification:

Class II

Date Initiated: January 30, 2023

Date Posted: March 15, 2023

Recall Number: Z-1210-2023

Event ID: 91504

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.

Status: Ongoing

Product Quantity: 4142

Code Information:

UDI-DI: 20816101026962. Product REF/Lot/Reaction Mix REF/Lot: MOL2655/13648N/MOL2656/13649N, MOL2655/13882N/MOL2656/15164N, MOL2655/15279N/MOL2656/15280N

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.

Voluntary or Mandated:

Voluntary: Firm initiated