FDAClass IIAugust 12, 2026

Brand Name: DASH Rapid PCR Instrument Product Name recall: Software Issue

Brand Name: DASH Rapid PCR Instrument Product Name: DASH Rapid PCR Instrument Model/Catalog Number: SG-0002 Software Version: 6.0.2 Product…

Why was Brand Name: DASH Rapid PCR Instrument Product Name recalled?

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

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot Code: SN: C01250010; UDI: (01)00850063063005(11)250218(21)C01250010; SW: 6.0.2 SN: C02250006; UDI:(01)00850063063005(11)250225(21)C02250006; SW: 6.0.2

Product
Brand Name: DASH Rapid PCR Instrument Product Name: DASH Rapid PCR Instrument Model/Catalog Number: SG-0002 Software Version: 6.0.2 Product…
Recalling firm
Nuclein LLC
Quantity
2
Distribution
US Nationwide distribution in the state of Texas.
Recall date
August 12, 2026
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls