Lower risk Medical device recall · FDA · Published June 14, 2023

DiaSorin Simplexa Direct Amplification Disc Kit Recall: Liquid Spillage Risk

DiaSorin recalls Simplexa Direct Amplification Disc Kit (Rx Only) due to potential liquid spillage from malfunctioning discs. Affected units include specific lot codes and reference numbers.

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

🇺🇸 FDA recall #Z-2153-2023Medical device DiaSorin ›

Lower-risk recall

There is a potential for the direct amplification disc to malfunction which may result in spillage of liquid from the disc.

Take action

Contact the company

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

✎ GovInfoNow plain-language explainer

DiaSorin is recalling Simplexa Direct Amplification Disc Kits (Rx Only) because they may spill liquid if they malfunction. This could lead to contamination or damage to surfaces. The recall affects specific lot codes and reference numbers. Read more at govinfonow.com/recall/57849-diasorin-simplexa-direct-amplification-disc-kit-recall-liquid-spillage-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/57849-diasorin-simplexa-direct-amplification-disc-kit-recall-liquid-spillage-risk · Updated August 19, 2026 · FDA enforcement record: FDA #Z-2153-2023

Cite this page

“DiaSorin Simplexa Direct Amplification Disc Kit Recall: Liquid Spillage Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/57849-diasorin-simplexa-direct-amplification-disc-kit-recall-liquid-spillage-risk. Based on FDA recall #Z-2153-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2153-2023%22&limit=1).

DiaSorin Molecular LLC recalled Simplexa Direct Amplification Disc Kits (REF: MOL1455) due to potential disc malfunction and liquid spillage, according to the FDA on June 14, 2023. The voluntary Class II recall affects worldwide distribution.

How to tell if you have it

Brand: DiaSorin
Product: Simplexa Direct Amplification Disc Kit
REF: MOL1455
Kit lot codes: P17044N, P17052N, P17301N, P17302N, P17303N, P17304N, P17305N, P17306N, P17351N, P17352N, P17353N, P17354N, P17614N, P17625N, P17650N, P17652N, P17653N, P17654N, P17687N, P17688N, P17731N
Disc lot codes (REF: MOL1452): P15886N, P16794N, P16795N, P16796N, P16883N, P16885N, P17022N, P17056N, P17057N, P17047N, P17023N, P17176N, P17177N, P17294N, P17178N, P17295N, P17359N, P17362N, P17296N, P17361N, P17046N
UDI-DI: 01-30816101025092

The hazard

The direct amplification disc may malfunction, which can result in spillage of liquid from the disc. The FDA classified this as a Class II recall.

Context

GovInfoNow's records show DiaSorin Molecular LLC has issued four other recalls since May 12, 2020. On January 30, 2023, the company recalled Simplexa COVID-19 Direct Test Kits due to potential leakage causing invalid results. Other recent recalls of similar products include Medline Convenience Kits Recall (July 10, 2026) and Diasol 100225-10-DEX100 Dialysis Liquid Recall (November 5, 2025).

How to tell if you have this one

Check for the product reference number MOL1455 on the disc pouch or box. Look for specific lot codes like P17044N through P17731N listed in the product description.

Brand
DiaSorin
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Product Details
Verify the reference number MOL1455 and lot codes on the disc pouch or box to confirm if your unit is affected.

Where it went and when

Where it was distributed

Distributed nationwide and abroad; the notice names 42 states.

FDA distribution: “Worldwide - US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, PA, RI, SD, TN, TX, VA, VT, WA, WI, WV…” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Alabama, Arizona, Arkansas, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Hawaii, Idaho, 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, Oklahoma, Pennsylvania, Rhode Island, South Dakota, Tennessee, Texas, Vermont, Virginia, Washington, West Virginia, Wisconsin.

Recall timeline

FDA published this recall 42 days after the firm started it.

Jun 14, 2023Firm started the recall
Jul 18, 2023FDA classified it Class II
Jul 26, 2023Published in FDA’s Enforcement Report

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

✎ GovInfoNow

Questions people ask

From the GovInfoNow team · based on the FDA notice · How we make summaries

Is this product safe to use?

The product may malfunction and spill liquid, so it is not recommended for use until the recall remedy is applied.

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Keep exploring

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Link to this recall

<a href="https://govinfonow.com/recall/57849-diasorin-simplexa-direct-amplification-disc-kit-recall-liquid-spillage-risk">DiaSorin Simplexa Direct Amplification Disc Kit Recall: Liquid Spillage Risk (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-2153-2023 (June 14, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2153-2023 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.