QuickVue Dipstick Strep A Test Recall
Areazine synthesizes this FDA recall directly from FDA's official public data feed. See our methodology for full source attribution and refresh cadence.
Quidel Corporation is recalling 12,279 units of QuickVue Dipstick Strep A Test due to potential false positive results.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on June 2, 2026 and geographically references United States. Its severity classification of "medium" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.
Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, Devices.
What Happened
The recall was initiated due to the product having the potential for false positive results.
Which Products Are Affected
QuickVue Dipstick Strep A Test, 50T, REF 20108. Affected lot numbers: 225788, 228322, 233274. UDI/DI: 30014613201083. A total of 12,279 units are affected. Distribution was nationwide in the United States, including the states of AL, CA, FL, ID, IL, LA, MA, MD, MN, MO, NY, PA, SC, TN, TX, and VA. Recall number Z-2169-2026. Recalling firm: Quidel Corporation, 10165 McKellar Ct, San Diego, CA 92121-4201.
What You Should Do
No specific consumer instructions are provided in the recall notice.
Why This Matters
This ongoing Class II recall affects over 12,000 test units distributed across multiple states.
Source
FDA Enforcement Report, recall number Z-2169-2026.
Original source: FDA Official Notice ↗
Related FDA Recalls
All FDA Recalls →Nationwide notices with similar length or severity timing 8
Two Areazine-derived peer sets for this FDA recall: nearest notices by body length and by same severity near the same agency date. Peers come from other categories so they are not the same-feed Related list above.
Similar body length
Nearest notices by article body length (818 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to June 2, 2026.
Frequently Asked Questions
Common questions about this FDA recall.