QuickVue Dipstick Strep A Test, 50T, REF 20108, antigens, all groups, streptococcus spp.
Summary
The FDA issued a Class II for QuickVue Dipstick Strep A Test, 50T, REF 20108, antigens, all groups, streptococ by Quidel Corporation. Reason: Product has the potential for false positive results.
Details
Source
Device Recall
External ID
Z-2169-2026
Action Date
2026-05-20
Status
Ongoing
Category
device
Product Description
QuickVue Dipstick Strep A Test, 50T, REF 20108, antigens, all groups, streptococcus spp.
Lot/Code Info: UDI/DI 30014613201083, Lot Numbers: 225788, 228322, 233274.
Quantity Affected: 12279 units
Reason for Recall
Product has the potential for false positive results
Distribution
US Nationwide distribution in the states of AL, CA, FL, ID, IL, LA, MA, MD, MN, MO, NY, PA, SC, TN, TX, VA.
Type: Voluntary: Firm initiated
Recall Initiated: 2026-04-06
Company
San Diego, CA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 243 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Quidel Corporation has 14 FDA actions in our database, including 8 recalls and 6 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Quidel Corporation) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Quidel Corporation have FDA actions?
Quidel Corporation has 14 FDA actions in our database, including 8 recalls and 6 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2169-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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