DiaSorin Molecular LLC: Medical Device Recall in 2021 - (Recall #: Z-0162-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: September 23, 2021

Date Posted: October 27, 2021

Recall Number: Z-0162-2022

Event ID: 88825

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.

Status: Ongoing

Product Quantity: 1690 kits

Code Information:

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

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.

Voluntary or Mandated:

Voluntary: Firm initiated