Nuclein LLC: Medical Device Recall in 2025 - (Recall #: Z-2274-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: June 25, 2025

Date Posted: August 13, 2025

Recall Number: Z-2274-2025

Event ID: 97228

Reason for Recall:

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

Status: Ongoing

Product Quantity: 710 units

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

Voluntary or Mandated:

Voluntary: Firm initiated