FDA Device recall Z-2169-2026
QuickVue Dipstick Strep A Test, 50T, REF 20108, antigens, all groups, streptococcus spp
- FDA Device
- Class II
- ongoing
- Published 2026-05-20
On 2026-05-20 the FDA classified a Class II recall of QuickVue Dipstick Strep A Test, 50T, REF 20108, antigens, all groups, streptococcus spp by Quidel, citing product has the potential for false positive results.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2169-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-04-06 |
| Published | 2026-05-20 |
| Last updated | 2026-09-13 11:58 UTC |
| Company | Quidel |
| Distribution | US |
Product
QuickVue Dipstick Strep A Test, 50T, REF 20108, antigens, all groups, streptococcus spp.
Reason
Product has the potential for false positive results
Identifiers
| code_info | UDI/DI 30014613201083, Lot Numbers: 225788, 228322, 233274. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2169-2026%22
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