FDA Medical Device Recalls (openFDA)
DiaSorin Molecular LLC: Simplexa Direct Amplification Disc Kit, Product Kit Code MOL1455
- Recall number
- Z-0457-2022
- Recalling firm
- DiaSorin Molecular LLC
- Product
- Simplexa Direct Amplification Disc Kit, Product Kit Code MOL1455
- Status
- Open, Classified
- Initiated
- 2021-11-19
- Posted
- not on file
- Terminated
- not on file
- Reason
- 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.
- 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 technicalinfo.molecular@DiaSorin.com."
- Quantity
- 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.
- Lot, serial or model codes
- 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.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- OOI
- Firm FEI
- 2023365
- Firm city
- Cypress
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28