Strep A Test Recall: Quidel 20108/20125/20108SC
Announced 2026-05-20 · FDA
Dipstick strep A test has potential for false positive results. The recall covers 22,470 units distributed worldwide, including in the US (MA, NJ, MD, NC, SC, FL, TN, MS, MN, IL, MO, KS, LA, TX, CO, ID, CA, AK, NY, PA) and in countries such as Canada, Italy, Denmark, Norway, Sweden, Finland, Thailand, Israel, Slovenia, and Turkey. No corrective action is specified in the recall notice.
| Brand | Quidel Corporation |
|---|---|
| Product | QuickVue: Dipstick Strep A Test: 50T, REF: 20108; 25T, REF: 20125; 50T, SCN, REF: 20108SC |
| Reason | Dipstick strep A test has potential for false positive results. |
| Severity | moderate |
| Units affected | 12279 |
| 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. |
| Agency | FDA |
| Recall / campaign no. | REF/UDI-DI/Lot(Expiration): 20108/30014613201083/709673(05-FEB-2026), 709676(05-FEB-2026), 709484(09-JAN-2026), 709501(09-JAN-2026), 709520(16-JAN-2026), 709535(16-JAN-2026); 20125/30014613201250/709487(09-JAN-2026), 709503(16-JAN-2026), 709509(16-JAN-2026), 709684(12-FEB-2026); 20108SC/0130014613330073/709485(09-JAN-2026), 709502(16-JAN-2026) |
WHAT YOU SHOULD DO
- Stop using the affected test kits.
- Check your kit’s lot numbers (20108, 20108SC, 20125) and expiration dates and discard or return them per instructions.
- Contact Quidel or the FDA for guidance on replacement or return and report any adverse events.
- If you used the test and got a positive result, consult a healthcare professional for confirmation.
This is an automatically maintained record of an official recall notice. Details can change; always follow the official notice linked above. See all records in the Recall Database.