QuickVue recallZ-2545-2025 · Quidel Corporation · initiated Jun 17, 2025
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Quidel Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Dipstick strep A test has potential for false positive results.
FDA root cause category: Under Investigation by firm
What the company is doing
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].
Recall details
- Recall number
- Z-2545-2025
- Status
- Open, Classified
- Initiated by the company
- Jun 17, 2025
- Posted by the FDA
- Sep 10, 2025
- Recalling firm
- Quidel Corporation
- Quantity
- 22470
- Product code
- GTY
- FDA submissions
- K011097
- 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 description
QuickVue: Dipstick Strep A Test: 50T, REF: 20108; 25T, REF: 20125; 50T, SCN, REF: 20108SC
Code information (models, lots, serial numbers)
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)
Devices named in this recall
2 devices in the FDA device registry whose identifier appears in the recall's code information.
- QuickVue 20108Quidel Corporation · ANTIGENS, ALL GROUPS, STREPTOCOCCUS SPP.2 recalls0 reports
- QuickVue 20125Quidel Corporation · ANTIGENS, ALL GROUPS, STREPTOCOCCUS SPP.1 recall0 reports
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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