QuickVue: Dipstick Strep A Test: 50T, REF: 20108; 25T, REF: 20125; 50T, SCN, REF: 20108SC
FDA device recall Z-2545-2025 · posted 2025-09-10 · Open, Classified
Recall details
- Recalling firm
- Quidel Corporation
- Reason for recall
- Dipstick strep A test has potential for false positive results.
- Action taken
- 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 RA-OCDUS-CONFIRMAD@QUIDELORTHO.COM If you have further questions, please contact the firm's Global Services Organization at 1-800-874-1517 or technicalsupport@quidelortho.com.
- Root cause
- Under Investigation by firm
- Status
- Open, Classified
- Product code
- GTY
- Quantity affected
- 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, Finl
- Date initiated
- 2025-06-17
- Date posted
- 2025-09-10
- Location
- San Diego, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| QUICKVUE DIPSTICK STREP A (K011097) | Quidel Corp. | 2001-05-08 |