Class 2 Device Recall Simplexa Direct Amplification Disc Kit

• Date Initiated by Firm: November 19, 2021
• Create Date: January 05, 2022
• Recall Status: Open, Classified
• Recall Number: Z-0457-2022
• Recall Event ID: 89098
• Product Classification: real time Nucleic acid amplification system - Product Code OOI
• Product: Simplexa Direct Amplification Disc Kit, Product Kit Code MOL1455
• Code Information: 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.
• FEI Number: 2023365
• Recalling Firm/ Manufacturer: DiaSorin Molecular LLC; 11331 Valley View St; Cypress CA 90630-5366
• For Additional Information Contact: Ms. Alesia Magon; 651-472-3186
• Manufacturer 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 Determined 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 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.