Recall Z-2545-2025 ยท GTY Antigens, All Groups, Streptococcus Spp.
Quidel Corporation
QuickVue: Dipstick Strep A Test: 50T, REF: 20108; 25T, REF: 20125; 50T, SCN, REF: 20108SC
| Date | Sep 10, 2025 (initiated Jun 17, 2025) |
| Status | Open, Classified |
| Reason | Dipstick strep A test has potential for false positive results. |
| 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 RA-OCDUS-CONFIRMAD@QUIDELORTHO.COM If you have further questions, please contact the firm's Global Services Organization at 1-800-874-1517 |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K011097 | QUICKVUE DIPSTICK STREP A Quidel Corp., May 8, 2001 |