Strep A Test Recall: Quidel 20108/20125/20108SC
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 |
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.
How to identify the recalled item
| Lot / date codes | 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) |
|---|---|
| Lot / date codes | UDI/DI 30014613201083, Lot Numbers: 225788, 228322, 233274. |
These are the identifiers FDA published for this recall. Most recall notices list no UPC or model number at all — if the code on your item is not shown here, that does not mean the item is excluded. Check the official notice, or contact the company.
Other strep a test recalls
- Strep A Test Recall: Altruan Clearest Cassette · 2026-03-18
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.