FDA Class II · Medical device · August 12, 2026
Brand Name recall — Nuclein LLC
Due to a software issue which may result in false co-infection (e.g., Positive for Flu A, when SARS-CoV-2 is present).
Official ID Z-2861-2026 · Official record ↗
Nuclein recalls
Recall found. Nuclein is named in FDA Class II recall Z-2861-2026 covering Brand Name. 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). Identifying details: 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. Status: Ongoing.
Models with recalls
All Nuclein recalls
Verify with the official sources:
- CPSC — consumer products ↗ (aggregated here)
- NHTSA — vehicles, car seats, tires ↗ (aggregated here; use NHTSA's VIN lookup to check a specific vehicle)
- FDA — food, drugs, medical devices ↗ (aggregated here)
- USDA FSIS — meat, poultry & processed egg products ↗ (not aggregated here)
- Recalls.gov — the U.S. government’s all-agency portal ↗
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Compiled from official public-domain government data. Last checked September 7, 2026 at 6:00 AM UTC.