DeviceSignal · Recall classified
Nuclein LLC
FDA classified a device recall on 2026-08-03 · Class II · Z-2861-2026
EventRecall classified
Effective2026-08-03
ClassificationClass II
On 2026-08-03 the FDA classified a device recall from Nuclein LLC as Class II. Product: Brand Name: DASH Rapid PCR Instrument Product Name: DASH Rapid PCR Instrument…. Recall Z-2861-2026. The firm initiated it on 2025-06-25. This reports the classification FDA published on that date.
Reported facts
- Recall number
- Z-2861-2026
- Classification
- Class II
- Classified on
- 2026-08-03
- Initiated on
- 2025-06-25
- Firm
- Nuclein LLC
- Reason
- Due to a software issue which may result in false co-infection (e.g., Positive for Flu A, when SARS-CoV-2 is present).
- 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.
Every field above is as fda_device_enforcement published it. Nothing on this page is our interpretation.
Provenance
- Source
- fda_device_enforcement
- Source record
Z-2861-2026- Snapshot hash
ab5ada73bf212eb52a548aab0968a0fcee42807c61b0350e60e24bb6e2beed72- Source URL
- https://download.open.fda.gov/device/enforcement/device-enforcement-0001-of-0001.json.zip
- Observed
- 2026-09-08T16:22:09.483Z
- Transform
fda_device_enforcement_to_recall v1- Event rule
fda_device_recall_classified v1- Event key
9afa111fd4abb6f70dd9fc17f5841821d88e72e023fb185dc52d20ed57c4ea91- Signal type
device_recall.classified
Source terms that apply
- This is not a public alerting service and must not be used to notify patients or the public
- We do not report whether a recall is still open; FDA does not maintain that after classification
- Nothing here is a medical or clinical decision aid
- Not affiliated with, endorsed by, or certified by the FDA
Data provided by the U.S. Food and Drug Administration (https://open.fda.gov)