CLASS II ONGOING Device recall · Reported 13 Aug 2025 · FDA Enforcement Report
Dash Sars-CoV-2 & Flu A/B Test recalled by Nuclein
Nuclein is recalling Dash Sars-CoV-2 & Flu A/B Test, distributed in Florida, New York, Texas, West Virginia. The recall was initiated on 25 Jun 2025 and the FDA has classified it as Class II.
Check your package
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-2274-2025
- FDA event ID
- 97228
- Recalling firm
- Nuclein, Austin, TX
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 25 Jun 2025
- FDA classified
- 6 Aug 2025
- Reported
- 13 Aug 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Potency & Assay
- Device type
- Test Kits & Diagnostics
Timeline
| 25 Jun 2025 | Recall initiated by company | |
| 6 Aug 2025 | Classified by FDA | +42 days |
| 13 Aug 2025 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Due to manufacturing error, assay test may result in missed diagnosis or delay of treatment. (Potential false negative result)
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
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.
Where it was distributed
US distribution to: Florida, New York, Texas, and West Virginia
Questions about this recall
Why was it recalled?
Due to manufacturing error, assay test may result in missed diagnosis or delay of treatment. (Potential false negative result)
Which lots are affected?
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
Where was it sold?
US distribution to: Florida, New York, Texas, and West Virginia
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.
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