QuickVue recallZ-2169-2026 · Quidel Corporation · initiated Apr 6, 2026
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
Product has the potential for false positive results
FDA root cause category: Under Investigation by firm
What the company is doing
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."
Recall details
- Recall number
- Z-2169-2026
- Status
- Open, Classified
- Initiated by the company
- Apr 6, 2026
- Posted by the FDA
- May 12, 2026
- Recalling firm
- Quidel Corporation
- Quantity
- 12279 units
- Product code
- GTY
- FDA submissions
- K011097
- 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 description
QuickVue Dipstick Strep A Test, 50T, REF 20108, antigens, all groups, streptococcus spp.
Code information (models, lots, serial numbers)
UDI/DI 30014613201083, Lot Numbers: 225788, 228322, 233274.
Devices named in this recall
1 device 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
Product lines
Other devices under the same FDA submission
1 device cleared under K011097 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- QuickVue 20125Quidel Corporation · ANTIGENS, ALL GROUPS, STREPTOCOCCUS SPP.1 recall0 reports
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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