CLASS II ONGOING Device recall · Reported 26 Jul 2023 · FDA Enforcement Report

Simplexa Direct Amplification Disc Kit recalled by DiaSorin Molecular

DiaSorin Molecular is recalling Simplexa Direct Amplification Disc Kit, distributed nationwide in the US. The recall was initiated on 14 Jun 2023 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesMOL1455 UDI-DI: 01-30816101025092 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 MOL1452 disc lot codes: P15886N P16794N P16795N P16796N P16883N P16885N P17022N P17056N P17057N P17047N P17023N P17176N P17177N P17294N P17178N P17295N P17359N P17362N P17296N P17361N P17046N

Quantity recalled4,7878 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2153-2023
FDA event ID: 92559
Recalling firm: DiaSorin Molecular, Cypress, CA
Classification: Class II
Status: Ongoing
Recall initiated: 14 Jun 2023
FDA classified: 18 Jul 2023
Reported: 26 Jul 2023
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Packaging Defects
Device type: Other Medical Devices

Timeline

14 Jun 2023	Recall initiated by company
18 Jul 2023	Classified by FDA	+34 days
26 Jul 2023	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.

Product as listed by the FDA

Simplexa Direct Amplification Disc Kit, Rx Only, IVD The Simplexa Direct Amplification Disc Kit, REF: MOL1455 is 1 box containing 3 Direct Amplification Discs (DADs). Each box contains discs individually pouch-sealed and labeled with REF: MOL1452

Where it was distributed

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 and the countries of Bangladesh, Canada, Israel, Italy.

Nationwide Alabama Arkansas Arizona California Colorado Connecticut District of Columbia Florida Georgia Hawaii Iowa Idaho Illinois Indiana Kansas Kentucky Louisiana Massachusetts Maryland Maine

Questions about this recall

Is Simplexa Direct Amplification Disc Kit recalled?

Yes. DiaSorin Molecular recalled Simplexa Direct Amplification Disc Kit on 14 Jun 2023. The recall is Class II and its status is Ongoing. Recall number Z-2153-2023.

Why was it recalled?

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

Which lots are affected?

MOL1455 UDI-DI: 01-30816101025092 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 MOL1452 disc lot codes: P15886N P16794N P16795N P16796N P16883N P16885N P17022N P17056N P17057N P17047N P17023N P17176N P17177N P17294N P17178N P17295N P17359N P17362N P17296N P17361N P17046N

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from DiaSorin Molecular

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Reported	Class	Recall	Company	Reason	Where
15 Mar 2023Device	CLASS II	Simplexa Flu A/B & RSV Direct Gen II recalled by DiaSorin Molecular	DiaSorin Molecular	Potency & Assay	Nationwide
15 Mar 2023Device	CLASS II	Simplexa Covid-19 Direct recalled by DiaSorin Molecular	DiaSorin Molecular	Potency & Assay	Nationwide
12 Jan 2022Device	CLASS II	Simplexa Direct Amplification Disc Kit, Product Kit recalled	DiaSorin Molecular	Packaging Defects	41 states
27 Oct 2021Device	CLASS II	Simplexa Covid-19 Positive Control Pack recalled by DiaSorin Molecular	DiaSorin Molecular	Other	Nationwide
22 Jul 2020Device	CLASS II	MOL3650 Simplexa VZV Direct recalled by DiaSorin Molecular	DiaSorin Molecular	Potency & Assay	Nationwide

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