Recall Z-2169-2026 ยท GTY Antigens, All Groups, Streptococcus Spp.
Quidel Corporation
QuickVue Dipstick Strep A Test, 50T, REF 20108, antigens, all groups, streptococcus spp.
| Date | May 12, 2026 (initiated Apr 6, 2026) |
| Status | Open, Classified |
| Reason | Product has the potential for false positive results |
| Root cause | Under Investigation by firm |
| Action | QuidelOrtho issued an URGENT PRODUCT CORRECTION NOTIFICATION to its consignees on 4/6/2026 via courier (FedEx). The notice explained the problem, impact to results, and requested the following: "REQUIRED ACTION " Discontinue using, render unusable, and discard your remaining inventory of the above listed lots of QuickVue Dipstick Strep A Test. " Review the content of this communication with your Medical Director and retain this letter for your laboratory. " Complete and return the enclosed Confirmation of Receipt form no later than April 13, 2026. Upon receipt of your completed Confirmation |
| Quantity | 12279 units |
| Distribution | US Nationwide distribution in the states of AL, CA, FL, ID, IL, LA, MA, MD, MN, MO, NY, PA, SC, TN, TX, VA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K011097 | QUICKVUE DIPSTICK STREP A Quidel Corp., May 8, 2001 |