Roche Recalls cobas SARS-CoV-2 and Influenza Assay Reagents
Roche is recalling cobas SARS-CoV-2 & Influenza A/B assay reagents because they may produce invalid or false positive results.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a diagnostic medical device that may produce false positive results, which is a risk-of-harm product where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Roche Molecular Systems, Inc. is recalling the cobas SARS-CoV-2 & Influenza A/B assay reagents for use on the cobas Liat System. The recall affects 143,823 kits in the United States and 57,219 kits outside the United States. All lot numbers are included in this recall.
The recall was initiated because the assay may produce invalid or false positive results for one or more targets, including SARS-CoV-2, Influenza A, and Influenza B. The source text notes that affected tests showed abnormal PCR growth curves. The product was used under emergency use authorization.
Healthcare facilities and laboratories should stop using the affected reagents and contact Roche for instructions on how to return or dispose of the product. Users should verify their inventory against the catalog number 09211101190.
The recalled product
- 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
- Manufacturer
- Roche Molecular Systems, Inc.
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All lot numbers
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Roche Molecular Systems, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
Same manufacturer · Roche Molecular Systems, Inc.
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