Z-2545-2025Class II

QuickVue: Dipstick Strep A Test: 50T, REF: 20108; 25T, REF: 20125; 50T, SCN, REF: 20108SC

Name: Z-2545-2025 QuickVue: Dipstick Strep A Test: 50T, REF: 20108; 25T, REF: 20125; 50T, SCN, REF: 20108SC
Creator: Quidel Corporation
Published: 2025-06-17
License: https://open.fda.gov/license/

Ortho-Clinical Diagnostics, Inc. / initiated 2025-06-17 / Open, Classified

FDA source

Quidel Corporation began a recall of QuickVue: Dipstick Strep A Test: 50T, REF: 20108; 25T, REF: 20125; 50T, SCN, REF: 20108SC on 2025-06-17. FDA classified it as Class II and gives the reason as "Dipstick strep A test has potential for false positive results". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-2545-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-06-17
Posted: 2025-09-10
Recalling firm: Ortho-Clinical Diagnostics, Inc.
Product: QuickVue: Dipstick Strep A Test: 50T, REF: 20108; 25T, REF: 20125; 50T, SCN, REF: 20108SC
Product code: GTY Antigens, All Groups, Streptococcus Spp.
Reason for recall: Dipstick strep A test has potential for false positive results.
FDA root cause: Under Investigation by firm
Action: On 6/17/2025, correction notices were mailed to customers who were asked to do the following: 1) Send the enclosed customer letter and Confirmation of Receipt form to customers who were shipped any of the affected lots of Strep A Test from your facility. 2) The response form asks customers to acknowledge they have discontinued distributing and discarded the affected lots of Strep A Test 3) Complete and return the Confirmation of Receipt form via email to [email protected] If you have further questions, please contact the firm's Global Services Organization at 1-800-874-1517 or [email protected].
Quantity in commerce: 22470
Distribution: Worldwide - US Nationwide distribution in the states of MA, NJ, MD, NC, SC, FL, TN, MS, MN, IL, MO, KS, LA, TX, CO, ID, CA, AK, NY, PA and the countries of Canada, Italy, Denmark, Norway, Sweden, Finland, Thailand, Israel, Slovenia, Turkey.
Product codes and lots: REF/UDI-DI/Lot(Expiration): 20108/30014613201083/709673(05-FEB-2026), 709676(05-FEB-2026), 709484(09-JAN-2026), 709501(09-JAN-2026), 709520(16-JAN-2026), 709535(16-JAN-2026); 20125/30014613201250/709487(09-JAN-2026), 709503(16-JAN-2026), 709509(16-JAN-2026), 709684(12-FEB-2026); 20108SC/0130014613330073/709485(09-JAN-2026), 709502(16-JAN-2026)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2545-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2545-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-09-17	2025-09-10

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)