Use caution Medical device recall · FDA · Published November 19, 2021

DiaSorin Simplexa Disc Kit Recall: Leakage Risk with Reuse

DiaSorin recalls Simplexa Direct Amplification Disc Kit (MOL1455) due to potential leakage when reused, risking lab cross-contamination. Affected lots listed in product details.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-0457-2022Medical device DiaSorin ›

Use caution until it’s fixed

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.

Take action

Contact the company

Recalling firmDiaSorin Molecular LLC11331 Valley View St · Cypress, CA 90630-5366

✎ GovInfoNow plain-language explainer

DiaSorin is recalling a specific batch of Simplexa Direct Amplification Disc Kits because some discs can leak when reused with certain COVID-19 and flu tests. This leakage could cause cross-contamination in labs if not properly cleaned after a positive sample. Read more at govinfonow.com/recall/61521-diasorin-simplexa-disc-kit-recall-leakage-risk-with-reuse.

Source Summary by GovInfoNow · govinfonow.com/recall/61521-diasorin-simplexa-disc-kit-recall-leakage-risk-with-reuse · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0457-2022

Cite this page

“DiaSorin Simplexa Disc Kit Recall: Leakage Risk with Reuse.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61521-diasorin-simplexa-disc-kit-recall-leakage-risk-with-reuse. Based on FDA recall #Z-0457-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0457-2022%22&limit=1).

The FDA announced on 2021-11-19 that DiaSorin Molecular LLC is recalling Simplexa Direct Amplification Disc Kits due to leakage risks. The agency issued recall number Z-0457-2022 for the Class II device.

How to tell if you have it

Brand: DiaSorin
Product: Simplexa Direct Amplification Disc Kit, Product Kit Code MOL1455
Kit Lot numbers: 12410N, 12411N, 12413N, 12477N, 12602N, 12603N, 12721N, 12889N, 13369N, 13370N, 13434N, 13652N, and 13242N
Disc Lot numbers: 12152N, 12147N, 12149N, 12150N, 11548NA, 12144N, 12148N, 12151N, 12817N, 13151N, 12382N, 12835N, and 12154N
Units affected: 29495 kits

The hazard

A subset of affected discs is at risk of leakage when 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.

Context

GovInfoNow's records show DiaSorin Molecular LLC has 4 other recalls on record since 2020-05-12. Other recent recalls of similar products include DiaSorin Simplexa Direct Amplification Disc Kit Recall (2023-06-14), DiaSorin Simplexa Flu A/B & RSV Tests May Leak, Cause Invalid Results (2023-01-30), and DiaSorin SIMPLEXA COVID-19 Positive Control Pack Recall (2021-09-23). Other recent recalls of similar products include Milestone Vacuum Bag SU Large Specimen Container Recall (2026-03-09), Medline Convenience Kits Recall (2026-07-10), and Covidien EndoStitch Polysorb Loading Unit Recall (2026-04-15).

How to tell if you have this one

Check the kit lot numbers listed: 12410N, 12411N, 12413N, 12477N, 12602N, 12603N, 12721N, 12889N, 13369N, 13370N, 13434N, 13652N, and 13242N (disc lot numbers also listed). The kit contains 3 discs with product code MOL1452.

Brand
DiaSorin
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Kit Lot Numbers
Look for the kit lot numbers listed in the recall notice: 12410N, 12411N, 12413N, 12477N, 12602N, 12603N, 12721N, 12889N, 13369N, 13370N, 13434N, 13652N, and 13242N.

Where it went and when

Where it was distributed

Distributed in 39 states and D.C. and Puerto Rico, and outside the U.S.

FDA distribution: “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…” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Hawaii, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Missouri, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Vermont, Virginia, Washington, West Virginia, Wisconsin.

Recall timeline

FDA published this recall 54 days after the firm started it.

Nov 19, 2021Firm started the recall
Jan 5, 2022FDA classified it Class II
Jan 12, 2022Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/61521-diasorin-simplexa-disc-kit-recall-leakage-risk-with-reuse">DiaSorin Simplexa Disc Kit Recall: Leakage Risk with Reuse (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-0457-2022 (November 19, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0457-2022 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.