Nuclein DASH PCR instrument recalled for possible false results
Nuclein LLC is recalling the DASH Rapid PCR Instrument, model SG-0002 running software 6.0.2, because a software issue may produce false co-infection results, such as a positive for Flu A when SARS-CoV-2 is present. Two units were affected, and no injuries have been reported. The FDA has classified this as a Class II recall.
From the FDA notice · Read the official notice ↗
What to do
- Contact Nuclein LLC before using affected instruments; the notice does not specify a remedy.
- Check whether your instrument is model SG-0002 with software 6.0.2 and serial number C01250010 or C02250006.
- The notice doesn't say how to get a fix or replacement; ask Nuclein LLC for next steps.
Is yours affected?
Compare your label or packaging with the recalled product.
- Product
- Brand Name: DASH Rapid PCR Instrument Product Name: DASH Rapid PCR Instrument Model/Catalog Number: SG-0002 Software Version: 6.0.2 Product Description: The DASH¿ Rapid PCR Instrument (DASH Instrument) is an automated, fluorescence-based, reverse-transcription polymerase chain reaction (RT-PCR) instrument that extracts specimens and performs nucleic acid amplified tests (NAAT) in DASH test cartridges for the qualitative detection of infectious diseases. The DASH Instrument is intended for use in conjunction with DASH Rapid PCR System tests to aid in the diagnosis of infectious diseases. Component: No.
- Sold in
- Nationwide
- Made for
- All ages (under 100 years)
Details
- Units affected
- 2
- Illnesses reported
- None reported
- Manufactured in
- 8305 Cross Park Dr, Austin, TX, United States
- Classification
- Class II
- Recall number
- Z-2861-2026
In the FDA's words
- Description
- Brand Name: DASH Rapid PCR Instrument Product Name: DASH Rapid PCR Instrument Model/Catalog Number: SG-0002 Software Version: 6.0.2 Product Description: The DASH¿ Rapid PCR Instrument (DASH Instrument) is an automated, fluorescence-based, reverse-transcription polymerase chain reaction (RT-PCR) instrument that extracts specimens and performs nucleic acid amplified tests (NAAT) in DASH test cartridges for the qualitative detection of infectious diseases. The DASH Instrument is intended for use in conjunction with DASH Rapid PCR System tests to aid in the diagnosis of infectious diseases. Component: No. Due to a software issue which may result in false co-infection (e.g., Positive for Flu A, when SARS-CoV-2 is present). 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 Distribution: US Nationwide distribution in the state of Texas. Affected quantity: 2
- 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).