Z-2274-2025 Class II Ongoing
FDA device recall Z-2274-2025 was initiated by Nuclein LLC on June 25, 2025 and is designated Class II. Reason for recall: Due to manufacturing error, assay test may result in missed diagnosis or delay of treatment. (Potential false negative result) The recall status is ongoing. Affected quantity: 710 units.
Recall Details
- Product Type
- Devices
- Report Date
- August 13, 2025
- Initiation Date
- June 25, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 710 units
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.
Reason for Recall
Due to manufacturing error, assay test may result in missed diagnosis or delay of treatment. (Potential false negative result)
Distribution Pattern
US distribution to: Florida, New York, Texas, and West Virginia
Code Information
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