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Recall Observatory FDA recall evidence

Device 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.

Z-2274-2025

June 25, 2025

Class II

Product summary

Firm
Nuclein LLC
Event
Event 97228
Status
Ongoing
Classification
Class II
Quantity
710 units
Official record key
device-enforcement:Z-2274-2025

Official wording

Reason: Due to manufacturing error, assay test may result in missed diagnosis or delay of treatment. (Potential false negative result)

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

Distribution pattern: US distribution to: Florida, New York, Texas, and West Virginia

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    manufacturing error