CLASS II ONGOING Device recall · Reported 20 May 2026 · FDA Enforcement Report

QuickVue Dipstick Strep A Test, 50T recalled by Quidel

Quidel is recalling QuickVue Dipstick Strep A Test, 50T, distributed nationwide in the US. The recall was initiated on 6 Apr 2026 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesUDI/DI 30014613201083, Lot Numbers: 225788, 228322, 233274.

Quantity recalled12279 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2169-2026
FDA event ID: 98709
Recalling firm: Quidel, San Diego, CA
Classification: Class II
Status: Ongoing
Recall initiated: 6 Apr 2026
FDA classified: 12 May 2026
Reported: 20 May 2026
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Test Kits & Diagnostics

Timeline

6 Apr 2026	Recall initiated by company
12 May 2026	Classified by FDA	+36 days
20 May 2026	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Product has the potential for false positive results

Product as listed by the FDA

QuickVue Dipstick Strep A Test, 50T, REF 20108, antigens, all groups, streptococcus spp.

Where it was distributed

US Nationwide distribution in the states of AL, CA, FL, ID, IL, LA, MA, MD, MN, MO, NY, PA, SC, TN, TX, VA.

Nationwide Alabama California Florida Idaho Illinois Louisiana Massachusetts Maryland Minnesota Missouri New York Pennsylvania South Carolina Tennessee Texas Virginia

Questions about this recall

Why was it recalled?

Product has the potential for false positive results

Which lots are affected?

UDI/DI 30014613201083, Lot Numbers: 225788, 228322, 233274.

Where was it sold?

US Nationwide distribution in the states of AL, CA, FL, ID, IL, LA, MA, MD, MN, MO, NY, PA, SC, TN, TX, VA.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Quidel

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Reported	Class	Recall	Company	Reason	Where
17 Sep 2025Device	CLASS II	QuickVue: Dipstick Strep A Test: 50T recalled by Quidel	Quidel	Other	Nationwide
1 May 2024Device	CLASS II	InflammaDry MMP-9 Test recalled by Quidel	Quidel	Hidden Drug Ingredients	38 states
1 May 2024Device	CLASS II	InflammaDry MMP-9 Test recalled by Quidel	Quidel	Hidden Drug Ingredients	38 states
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