FDA Medical Device Recalls (openFDA)
Quidel Corporation: QuickVue Dipstick Strep A Test, 50T, REF 20108, antigens, all groups, streptococcus spp.
- Recall number
- Z-2169-2026
- Recalling firm
- Quidel Corporation
- Product
- QuickVue Dipstick Strep A Test, 50T, REF 20108, antigens, all groups, streptococcus spp.
- Status
- Open, Classified
- Initiated
- 2026-04-06
- Posted
- 2026-05-12
- Terminated
- not on file
- Reason
- Product has the potential for false positive results
- 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 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."
- Quantity
- 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.
- Lot, serial or model codes
- UDI/DI 30014613201083, Lot Numbers: 225788, 228322, 233274.
- 510(k) numbers
- ["K011097"]
- PMA numbers
- not on file
- Product code
- GTY
- Firm FEI
- 2024674
- Firm city
- San Diego
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28