RecallReported September 23, 2026
Class II recall by Nuclein LLC
Brand Name: DASH Rapid PCR Instrument Product Name: DASH Rapid PCR Instrument Model/Catalog Number: SG-0002 Software Version: 6.0.2, 6.0.4, …
FDA's enforcement report of September 23, 2026 lists a Class II recall by Nuclein LLC of Austin, TX. Product: Brand Name: DASH Rapid PCR Instrument Product Name: DASH Rapid PCR Instrument Model/Catalog Number: SG-0002 Software Version: 6.0.2, 6.0.4, …. Status: Ongoing.
On the record
- Recalling firm
- Nuclein LLC
- Location
- Austin, TX
- Classification
- Class II
- Status
- Ongoing
- Recall number
- Z-3164-2026
- Product type
- Devices
- Recall initiated
- 2025-10-22
- Reported by FDA
- 2026-09-23
The full record
An account shows the reason for the recall, where the product was distributed and the lots.
What a recall is
FDA classifies a recall by the hazard. Class I: a reasonable probability that the product will cause serious adverse health consequences or death. Class II: the product may cause temporary or medically reversible harm, or the probability of serious harm is remote. Class III: the product is not likely to cause adverse health consequences.
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From FDA enforcement reports. The record may have changed since it was read.
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