[Recalled] cobas SARS-CoV-2 & Influenza A/B assay cobas Liat- Reagents, 2019-Novel Coronavirus Nucleic Acid for use on the cobas Liat System, Catalog Number: 09211101190 — Invalid or false positive results for one or more targets (SARS-Co
Regulators flagged this product in an official safety action. Here is what the notice says and what it means for owners.
Recall details
| Product | cobas SARS-CoV-2 & Influenza A/B assay cobas Liat- Reagents, 2019-Novel Coronavirus Nucleic Acid for use on the cobas Liat System, Catalog Number: 09211101190 |
|---|---|
| Brand / manufacturer | Roche Molecular Systems, Inc. |
| Category | device |
| Issuing authority | FDA_DEVICE |
| Reference | Z-1413-2021 |
| Country of notice | United States |
| Risk level | Class II |
| Hazard type | recall |
| Notice date | 25 March 2021 |
| EAN / barcode | 09211101190 |
Why it was recalled
According to the FDA_DEVICE notice, the identified hazard is: Invalid or false positive results for one or more targets (SARS-CoV-2/Influenza A/Influenza B) using the cobas SARS-CoV-2 & Influenza A/B assay for use under emergency use authorization on the cobas Liat analyzer, showed abnormal PCR growth curves
This Class II recall concerns device products distributed in United States and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.
What to do if you own this product
Check whether your unit is affected and follow the authority's guidance before further use.
Read the full official notice →
Related recalls from Roche Molecular Systems, Inc.
This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.
- Best Calcium Sources for the Lactose Intolerant
- What is the meals category? Top brands, safety considerations, EU + US labeling regimes | ProductGuru
- The Healthiest Bedding and Pillows Options for Better Sleep and Wellbeing
- Best Value Other Snacks: Affordable, Nutritious Options for Every Occasion
- Understanding SPF Ratings and Choosing the Right Sunscreen for Your Needs - A Consumer Guide
- Qu'est-ce que (1S,2S,5R,6R,9S,10S,13R,14R)-1,6,7,8,9,14,15,16,17,17,18,18-Dodecachloropentacyclo[12.2.1.1⁶,⁹.0²,¹³.0⁵,¹⁰]octadeca-7,15-diene (CAS 135821-03-3) ? Sécurité, réglementation & perspective