FDA Medical devices recall ·
DASH SARS-CoV-2 & Flu A/B Test Model recall
- Recall number
- Z-2274-2025
- Date
- (initiated June 25, 2025)
- Company / brand
- Nuclein LLC
8305 Cross Park Dr, Austin, TX, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 710 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
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.
Why was it recalled?
Due to manufacturing error, assay test may result in missed diagnosis or delay of treatment. (Potential false negative result)
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
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
Distribution
US distribution to: Florida, New York, Texas, and West Virginia
States: Florida New York Texas West Virginia
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-2274-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.