DASH SARS-CoV-2 & Flu A/B Test Model/Catalog Number: SG-0006 combination COVID-19 and Flu test. Each DASH SARS-
Summary
The FDA issued a Class II for DASH SARS-CoV-2 & Flu A/B Test Model/Catalog Number: SG-0006 combination by Nuclein LLC. Reason: Due to manufacturing error, assay test may result in missed diagnosis or delay of treatment. (Potential false negative result).
Details
Source
Device Recall
External ID
Z-2274-2025
Action Date
2025-08-13
Status
Ongoing
Category
device
Product Description
DASH SARS-CoV-2 & Flu A/B Test Model/Catalog Number: SG-0006 combination COVID-19 and Flu test. Each DASH SARS-CoV-2 & Flu A/B Test is individually pouched and labeled. The tests are provided to users in quantities of 10 per kit. Used on the DASH instrument.
Lot/Code Info: Lot Code: Lot: BB02 UDI: (01)00850063063036(17)260220(10)BB02 Expiration Date: 20 Feb. 2026 Lot Code: Lot: BB03 UDI: (01)00850063063036(17)260220(10)BB03 Expiration Date: 20 Feb. 2026
Quantity Affected: 710 units
Reason for Recall
Due to manufacturing error, assay test may result in missed diagnosis or delay of treatment. (Potential false negative result)
Distribution
US distribution to: Florida, New York, Texas, and West Virginia
Type: Voluntary: Firm initiated
Recall Initiated: 2025-06-25
Company
Austin, TX
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 172 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Nuclein LLC has 2 FDA actions in our database, including 1 recall and 1 clearance.
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 (Nuclein LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Nuclein LLC have FDA actions?
Nuclein LLC has 2 FDA actions in our database, including 1 recall and 1 device clearance.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2274-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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