Key facts
| Recalling firm | Quidel Corporation |
|---|---|
| Manufacturer | Not disclosed in the FDA record. |
| Brand name | Not disclosed in the FDA record. |
| Product description | QuickVue Dipstick Strep A Test, 50T, REF 20108, antigens, all groups, streptococcus spp. |
| Classification | Class II |
| Recall number | Z-2169-2026 |
| Report date | Not disclosed in the FDA record. |
| Status | Ongoing |
| Reason for recall | Product has the potential for false positive results |
What consumers should do
Because this recall carries FDA's middle severity classification, anyone who has this product should stop using it and follow the recalling firm's instructions, even though serious harm is considered unlikely for this classification. Specifically, check whether the product in your possession matches the description on file with FDA -- QuickVue Dipstick Strep A Test, 50T, REF 20108, antigens, all groups, streptococcus spp. -- and the recall number Z-2169-2026. If it matches, stop using or distributing it and contact Quidel Corporation or the point of purchase for return or replacement instructions. Retailers and distributors holding affected inventory should quarantine it and follow the firm's written recall notice. FDA maintains a public enforcement report database so that consumers, physicians, and purchasers can look up the exact product identifiers involved before deciding what to do.
What this classification means
FDA classifies a recall as Class II when using the recalled product, or being exposed to it, may cause temporary or medically reversible adverse health consequences, or when the probability of serious adverse health consequences is remote. In this case, the recalling firm is Quidel Corporation and the affected product is described in FDA's record as: QuickVue Dipstick Strep A Test, 50T, REF 20108, antigens, all groups, streptococcus spp.. FDA's stated reason for the recall is: Product has the potential for false positive results. The recall is tracked under FDA recall number Z-2169-2026 and carries a status of Ongoing as of the most recent FDA enforcement report. This classification reflects FDA's assessment of the product defect described above, not a prediction about any specific patient outcome. FDA maintains a public enforcement report database so that consumers, physicians, and purchasers can look up the exact product identifiers involved before deciding what to do. Recall status can change while FDA and the recalling firm continue corrective actions, so checking the firm's own notice for the most current guidance is recommended. Adverse events believed to be related to a recalled product can be reported to FDA's MedWatch program, which FDA uses to monitor safety signals after a recall is opened.
Quidel Corporation’s FDA history
Argus HQ has recorded 1 total FDA action tied to Quidel Corporation: 0 warning letters, 1 recall, 0 approval records, and 0 Form 483 inspection citations.
Frequently asked questions
- What should someone who has this product do?
- Because this recall carries FDA's middle severity classification, anyone who has this product should stop using it and follow the recalling firm's instructions, even though serious harm is considered unlikely for this classification. Check the product against FDA's description (QuickVue Dipstick Strep A Test, 50T, REF 20108, antigens, all groups, streptococcus spp.) and recall number Z-2169-2026, then follow Quidel Corporation's recall instructions.
- Has Quidel Corporation had other FDA recalls or enforcement actions?
- This is the only FDA action Argus HQ has on file for Quidel Corporation so far. Argus ingests new FDA enforcement records daily.
- What is the FDA recall number for this event?
- FDA recall number Z-2169-2026.
- What is the current status of this recall?
- Status as recorded by FDA: Ongoing.
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Related enforcement actions
Full FDA history for Quidel CorporationCompiled by Argus HQ Research from FDA primary sources · Reviewed by Andy Gaber, Founder
Cite this record
Reusing this data in reporting or research? Here’s a ready-made citation.
Argus HQ Research (2026). FDA Class II Recall: QuickVue Dipstick Strep A Test, 50T, REF 20108,… by Quidel Corporation — Recall Details. Digital Empire Holdings LLC. Retrieved from https://argushq.ai/recall/fda-recall-quidel-corporation-z-2169-2026
"FDA Class II Recall: QuickVue Dipstick Strep A Test, 50T, REF 20108,… by Quidel Corporation — Recall Details." Argus HQ Research, Digital Empire Holdings LLC, 2026, argushq.ai/recall/fda-recall-quidel-corporation-z-2169-2026.
Argus HQ Research. "FDA Class II Recall: QuickVue Dipstick Strep A Test, 50T, REF 20108,… by Quidel Corporation — Recall Details." Digital Empire Holdings LLC. Accessed August 13, 2026. https://argushq.ai/recall/fda-recall-quidel-corporation-z-2169-2026.
@misc{argushq_argushq_ai_recall_fda_recall_quidel_corporation_z_2169_2026_2026,
title = {FDA Class II Recall: QuickVue Dipstick Strep A Test, 50T, REF 20108,… by Quidel Corporation — Recall Details},
author = {{Argus HQ Research}},
year = {2026},
publisher = {Digital Empire Holdings LLC},
url = {https://argushq.ai/recall/fda-recall-quidel-corporation-z-2169-2026},
note = {Accessed: August 13, 2026}
}Source: FDA.gov — Recalls ↗