Z-0457-2022Class II

Simplexa Direct Amplification Disc Kit, Product Kit Code MOL1455

Name: Z-0457-2022 Simplexa Direct Amplification Disc Kit, Product Kit Code MOL1455
Creator: DiaSorin Molecular LLC
Published: 2021-11-19
License: https://open.fda.gov/license/

DiaSorin Molecular LLC / initiated 2021-11-19 / Open, Classified

FDA source

DiaSorin Molecular LLC began a recall of Simplexa Direct Amplification Disc Kit, Product Kit Code MOL1455 on 2021-11-19. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-0457-2022
Classification: Class II
Status: Open, Classified
Initiated: 2021-11-19
Posted: 2022-01-05
Recalling firm: DiaSorin Molecular LLC
Product: Simplexa Direct Amplification Disc Kit, Product Kit Code MOL1455
Product code: OOI Real Time Nucleic Acid Amplification System
Reason for recall: 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: Under Investigation by firm
Action: 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]."
Quantity in commerce: 29495 kits
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 codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0457-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0457-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-01-12	2022-01-05

Product code OOI

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)