Class 2 Device Recall Simplexa Flu A/B & RSV Direct Gen II assay

• Date Initiated by Firm: January 30, 2023
• Date Posted: March 03, 2023
• Recall Status: Open, Classified
• Recall Number: Z-1210-2023
• Recall Event ID: 91504
• 510(K)Number: K201505
• Product Classification: Respiratory virus panel nucleic acid assay system - Product Code OCC
• Product: Simplexa Flu A/B & RSV Direct Gen II, REF: MOL2655; including Reaction Mix REF: MOL2656; with previous assay definition v5.
• Code Information: UDI-DI: 20816101026962. Product REF/Lot/Reaction Mix REF/Lot: MOL2655/13648N/MOL2656/13649N, MOL2655/13882N/MOL2656/15164N, MOL2655/15279N/MOL2656/15280N
• Recalling Firm/ Manufacturer: DiaSorin Molecular LLC; 11331 Valley View St; Cypress CA 90630-5366
• For Additional Information Contact: 714-220-1900
• Manufacturer Reason for Recall: Direct amplification Discs , used with COVID-19 and Flu A/B & RSV assays, may leak and cause contamination, cross-contamination, invalid results, and error codes.
• FDA Determined Cause: Device Design
• Action: On 01/30/2023, correction notices were distributed to customers via in-person site visits. Customers were asked to do the following: 1) Discontinue use of affected devices using affected assay definitions. 2) Customers can contact the recalling firm to replace affected kits. The firm can also provide assistance with inventory reconciliation/destruction, and if needed, assistance with potential instrument/lab decontamination. 3) Any sample result with an error code (EC510, EC515, RNA IC, Insufficient Specimen Volume) should be retested following the Instructions for Use. 4) 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. 5) This recall notice should be shared with anyone who needs to be aware within your organization or shared with any organization where the potentially affected products have been transferred. Notify others within your network that may have remaining inventory of those kits. 5) Complete and return the acknowledgement and receipt form and return to the recalling firm's Technical Service department at technicalinfo.molecular@diasorin.com Product in the field with the previous high spin assay definitions are being recalled and replaced with current products with the current reduced spin assay definitions. Customers with questions are encouraged to email (see above) or call Technical Service at (800) 838-4548, option 3, Monday - Friday, 7:00am to 5:00pm (Pacific Time)
• Quantity in Commerce: 4142
• Distribution: US Nationwide distribution including in the states of NJ, ME, ND, IL, MI, FL, GA, AZ, MA, CA, MO, SD, MN, PA, OH, VT, NE, WI, CO, DC, VA, TX, NH, IN, IA, MD, NC, AL, NY, KY, WV, RI, KS, NM, OK, WA, SC, CT, TN, NV, LA.
• 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.

• 510(K) Database: 510(K)s with Product Code = OCC