Nuclein LLC: 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 prov

Hazard

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

Details from the source

Reason for recall: Due to manufacturing error, assay test may result in missed diagnosis or delay of treatment. (Potential false negative result) Distribution: US distribution to: Florida, New York, Texas, and West Virginia Quantity: 710 units Lot/code info: 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

UPC codes

00850063063036

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.