DiaSorin Molecular LLC recalls Simplexa Direct Amplification Disc Kit, Product Kit Code MOL1455

Recall date

November 19, 2021

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0457-2022

FDA classification

Class II

Brand / firm

DiaSorin Molecular LLC

Sold / distributed

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 Arab Emirates.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Simplexa Direct Amplification Disc Kit, Product Kit Code MOL1455