Class 2 Device Recall QuickVue Dipstick Strep A Test

• Date Initiated by Firm: April 06, 2026
• Date Posted: May 12, 2026
• Recall Status: Open, Classified
• Recall Number: Z-2169-2026
• Recall Event ID: 98709
• 510(K)Number: K011097
• Product Classification: Antigens, all groups, streptococcus spp. - Product Code GTY
• Product: QuickVue Dipstick Strep A Test, 50T, REF 20108, antigens, all groups, streptococcus spp.
• Code Information: UDI/DI 30014613201083, Lot Numbers: 225788, 228322, 233274.
• FEI Number: 2024674
• Recalling Firm/ Manufacturer: Quidel Corporation; 10165 McKellar Ct; San Diego CA 92121-4201
• For Additional Information Contact: Laurie O'Riordan; 800-874-1517 Ext. 7922
• Manufacturer Reason for Recall: Product has the potential for false positive results
• FDA Determined Cause: Under Investigation by firm
• Action: QuidelOrtho issued an URGENT PRODUCT CORRECTION NOTIFICATION to its consignees on 4/6/2026 via courier (FedEx). The notice explained the problem, impact to results, and requested the following: "REQUIRED ACTION " Discontinue using, render unusable, and discard your remaining inventory of the above listed lots of QuickVue Dipstick Strep A Test. " Review the content of this communication with your Medical Director and retain this letter for your laboratory. " Complete and return the enclosed Confirmation of Receipt form no later than April 13, 2026. Upon receipt of your completed Confirmation of Receipt form, QuidelOrtho will credit or replace your discarded inventory, as needed. " Please forward this notification if the affected product was distributed outside of your facility." For questions, contact: Technical Support team at 1-800-874-1517 or technicalsupport@quidelortho.com. Distributors were requested to perform the following: "REQUIRED ACTION " Send the enclosed Customer Letter and Confirmation of Receipt form to all customers who have been shipped the affected lots of QuickVue" Dipstick Strep A Test from your facility. " Complete and return the enclosed Distributor Confirmation of Receipt form no later than April 13, 2026. " Please forward this notification if the affected product was distributed outside of your facility."
• Quantity in Commerce: 12279 units
• Distribution: US Nationwide distribution in the states of AL, CA, FL, ID, IL, LA, MA, MD, MN, MO, NY, PA, SC, TN, TX, VA.
• 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 = GTY