Z-2169-2026Class II

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

Name: Z-2169-2026 QuickVue Dipstick Strep A Test, 50T, REF 20108, antigens, all groups, streptococcus spp
Creator: Quidel Corporation
Published: 2026-04-06
License: https://open.fda.gov/license/

Ortho-Clinical Diagnostics, Inc. / initiated 2026-04-06 / Open, Classified

FDA source

Quidel Corporation began a recall of QuickVue Dipstick Strep A Test, 50T, REF 20108, antigens, all groups, streptococcus spp on 2026-04-06. FDA classified it as Class II and gives the reason as "Product has the potential for false positive results". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-2169-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-04-06
Posted: 2026-05-12
Recalling firm: Ortho-Clinical Diagnostics, Inc.
Product: QuickVue Dipstick Strep A Test, 50T, REF 20108, antigens, all groups, streptococcus spp.
Product code: GTY Antigens, All Groups, Streptococcus Spp.
Reason for recall: Product has the potential for false positive results
FDA root 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 [email protected]. 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.
Product codes and lots: UDI/DI 30014613201083, Lot Numbers: 225788, 228322, 233274.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2169-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2169-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-05-20	2026-05-12

Product code GTY

K011097Class IQuickvue Dipstick Strep aQuidel Corp. / cleared 2001-05-08

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)