QuickVue Dipstick Strep A Test, 50T, REF 20108, antigens, all groups, streptococcus spp.

FDA device recall Z-2169-2026 · posted 2026-05-12 · Open, Classified

Recall details

Recalling firm

Quidel Corporation

Reason for recall

Product has the potential for false positive results

Action taken

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."

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

GTY

Quantity affected

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.

Date initiated

2026-04-06

Date posted

2026-05-12

Location

San Diego, CA

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