QuickVue: Dipstick Strep A Test: 50T, REF: 20108; 25T, REF: 20125; 50T, SCN, REF: 20108SC
FDA Recall Z-2545-2025 · Posted 2025-09-10
Recalling FirmQuidel Corporation
Recall StatusOpen, Classified
Product CodeGTY
Date Initiated2025-06-17
Product Quantity22470
Reason for Recall
Dipstick strep A test has potential for false positive results.
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 [email protected]
If you have further questions, please contact the firm's Global Services Organization at 1-800-874-1517 or [email protected].
Root Cause
Under Investigation by firm
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.