DASH Rapid PCR Instrument Recall Issued by Nuclein LLC
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Nuclein LLC is recalling two DASH Rapid PCR Instruments due to a software issue that may cause false co-infection results.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on August 19, 2026 and geographically references United States. Its severity classification of "medium" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.
Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, Devices.
What Happened
Nuclein LLC is conducting a voluntary recall of the DASH Rapid PCR Instrument due to a software issue which may result in false co-infection (e.g., Positive for Flu A, when SARS-CoV-2 is present).
Which Products Are Affected
The recall involves the DASH Rapid PCR Instrument (Model/Catalog Number: SG-0002, Software Version: 6.0.2). Two units are affected with the following details: SN: C01250010 (UDI: (01)00850063063005(11)250218(21)C01250010; SW: 6.0.2) and SN: C02250006 (UDI:(01)00850063063005(11)250225(21)C02250006; SW: 6.0.2). Distribution was US Nationwide in the state of Texas.
What You Should Do
The recall was initiated by the firm via letter. Consumers with affected units should follow instructions provided in the notification from Nuclein LLC.
Why This Matters
The Class II recall addresses a software defect that could lead to incorrect infectious disease test results.
Source
FDA recall number Z-2861-2026. Event ID: 99360. Recalling firm: Nuclein LLC, Austin, TX.
Original source: FDA Official Notice ↗
Related FDA Recalls
All FDA Recalls →Nationwide notices with similar length or severity timing 8
Two Areazine-derived peer sets for this FDA recall: nearest notices by body length and by same severity near the same agency date. Peers come from other categories so they are not the same-feed Related list above.
Similar body length
Nearest notices by article body length (1,017 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to August 19, 2026.
Frequently Asked Questions
Common questions about this FDA recall.