Simplexa Direct Amplification Disc Kit, Product Kit Code… recallZ-0457-2022 · DiaSorin Molecular LLC · initiated Nov 19, 2021

Open, Classified

Is my device affected?

Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
If yours is listed, follow the instructions from DiaSorin Molecular LLC or your healthcare provider. The company's action is summarized under what the company is doing.
Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

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.

FDA root cause category: Under Investigation by firm

What the company is doing

On 11/19/2021, the firm notified affected customers via email of "URGENT: MEDICAL DEVICE CORRECTION NOTIFICATION." The letter indicated, "Actions to be taken by the Customer/User/Distributor: - Any remaining discs in inventory that are listed in the table below should only be used one time and not reused. - Any sample with an error code should be retested. - If leakage is suspected, the spillage should be removed and the instrument surface should be decontaminated. Ensure the practice of Good Laboratory Procedures including regular cleaning. - Notify others within your network that may have received these kits. - Complete and return the Acknowledgement and Receipt Form (page 3) of this notification letter. - If your firm has further distributed the devices, please share a copy of this correction notification and response form with those customers and provide a copy of the completed response form back to us. If you have any questions or if you would like replacement product for the Direct Amplification Discs you still have in stock, please contact DiaSorin Molecular Technical Service, Monday Friday, 7:00am to 5:00pm (Pacific Time) at (800) 838-4548, option 3, or by email at [email protected]."

Recall details

Recall number: Z-0457-2022
Status: Open, Classified
Initiated by the company: Nov 19, 2021
Recalling firm: DiaSorin Molecular LLC
Quantity: 29495 kits
Product code: OOI
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 Rico, United Arab Emirates.

Product description

Simplexa Direct Amplification Disc Kit, Product Kit Code MOL1455

Code information (models, lots, serial numbers)

Kit Product Code MOL1455 (UDI 01-30816101025092) contains 3 discs with Disc Product Code MOL1452. Below lists the MOL1455 Kit Lot numbers (and MOL1452 Disc Lot Numbers): 12410N (12152N), 12411N (12147N), 12413N (12149N), 12477N (12150N), 12602N (11548NA), 12603N (12144N), 12721N (12148N), 12889N (12151N), 13369N (12817N), 13370N (13151N), 13434N (12382N), 13652N (12835N), and 13242N (12154N)*. *Kit Lot #13242N (Disc Lot #12154N) was shipped to Europe and not within the US.

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Direct Amplification Disc Kit MOL1455
Diasorin Molecular LLC · Real Time Nucleic Acid Amplification System
2 recalls1 report

Sources and updates

Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.

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