FDA DeviceClass IINotable

FDA Recall: Brand Name: DASH Rapid PCR Instrument Product Name: DASH Rapid PCR Instrument Model/Catalog Number

Date: 2026-08-12
Brand: Nuclein LLC
Category: Medical Device
FDA Class: Class II

Description

Due to a software issue which may result in false co-infection (e.g., Positive for Flu A, when SARS-CoV-2 is present).

Hazard

Due to a software issue which may result in false co-infection (e.g., Positive for Flu A, when SARS-CoV-2 is present).

Remedy

2

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