Lower risk Medical device recall · FDA · Published September 23, 2021

DiaSorin SIMPLEXA COVID-19 Positive Control Pack Recall: Delayed Amplification Signals

DiaSorin recalls SIMPLEXA COVID-19 Positive Control Packs with unapproved materials that may cause delayed amplification signals. Affected units include specific lot numbers and expiration dates.

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

🇺🇸 FDA recall #Z-0162-2022Medical device DiaSorin ›

Lower-risk recall

Due to unapproved raw materials used in the manufacturing of Covid-19 control pack, their is the potential for delayed amplification signals.

Take action

Contact the company

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

✎ GovInfoNow plain-language explainer

DiaSorin is recalling certain SIMPLEXA COVID-19 Positive Control Packs due to unapproved materials that could cause delayed amplification signals. This affects lab tests used for COVID-19 testing and may lead to inaccurate results. Read more at govinfonow.com/recall/61757-diasorin-simplexa-covid-19-positive-control-pack-recall-delayed-amplification.

Source Summary by GovInfoNow · govinfonow.com/recall/61757-diasorin-simplexa-covid-19-positive-control-pack-recall-delayed-amplification · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0162-2022

Cite this page

“DiaSorin SIMPLEXA COVID-19 Positive Control Pack Recall: Delayed Amplification Signals.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61757-diasorin-simplexa-covid-19-positive-control-pack-recall-delayed-amplification. Based on FDA recall #Z-0162-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0162-2022%22&limit=1).

DiaSorin Molecular LLC recalled SIMPLEXA COVID-19 Positive Control Pack kits due to potential delayed amplification signals from unapproved raw materials, the FDA said on Sept. 23, 2021.

How to tell if you have it

Brand: DiaSorin
Product: SIMPLEXA COVID-19 Positive Control Pack, REF MOL4160, IVD, Rx Only, UDI: (01) 20816101027051
UPC: 20816101027051
Lot codes: 12175N, 12722N, X12122N, X12724N
Expiration dates: 11.30.2021, 01.31.2022, 08.31.2022
Quantity: 1690 kits

The hazard

The recall cites the potential for delayed amplification signals caused by unapproved raw materials used in manufacturing the control pack, according to the FDA.

Context

GovInfoNow's records show DiaSorin Molecular LLC has 4 other recalls on record since May 12, 2020. Other recent recalls of similar products include DiaSorin Simplexa Direct Amplification Disc Kit Recall (June 14, 2023), DiaSorin Simplexa COVID-19 Direct Test Kits May Leak, Cause Invalid Results (Jan. 30, 2023), and DiaSorin Simplexa Disc Kit Recall: Leakage Risk with Reuse (Nov. 19, 2021). Other recent recalls of similar products include GET TESTED D-Dimer Test Recall (Nov. 3, 2025), GET TESTED Mycotoxin Panel Test Recall (Nov. 3, 2025), and Biomerieux VITEK 2 AST-N461 Test Kit Recall (July 24, 2026).

How to tell if you have this one

Check the lot number and expiration date on the packaging. Affected units include lot numbers 12175N/11.30.2021, 12722N/01.31.2022, X12122N/01.31.2022, and X12724N/08.31.2022.

Brand
DiaSorin
Product
SIMPLEXA COVID-19 Positive Control Pack, REF MOL4160, IVD, Rx Only, UDI: (01) 20816101027051
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Product Details
Review the lot number and expiration date on the packaging to confirm if it matches the affected units listed.

Where it went and when

Where it was distributed

Distributed nationwide and abroad; the notice names 34 states.

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

Named in the notice: Alabama, Arizona, California, Colorado, Delaware, Florida, Georgia, Illinois, Indiana, Kansas, Kentucky, Maine, Maryland, Massachusetts, Michigan, Minnesota, Missouri, Nebraska, Nevada, New Jersey, New York, North Carolina, North Dakota, Ohio, Oklahoma, Pennsylvania, South Dakota, Tennessee, Texas, Vermont, Virginia, Washington, West Virginia, Wisconsin.

Recall timeline

FDA published this recall 34 days after the firm started it.

Sep 23, 2021Firm started the recall
Oct 21, 2021FDA classified it Class II
Oct 27, 2021Published 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/61757-diasorin-simplexa-covid-19-positive-control-pack-recall-delayed-amplification">DiaSorin SIMPLEXA COVID-19 Positive Control Pack Recall: Delayed Amplification Signals (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-0162-2022 (September 23, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0162-2022 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.