Reported Apr 6, 2022 · Ongoing
cobas LiatSystem, respiratory virus panel nucleic acid assay system, Material Number 07341920190
Roche Molecular Systems, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Roche Molecular Systems, Inc. · 1080 US Highway 202 S · Branchburg, NJ · 08876-3733
Is this the product you have?
- cobas LiatSystem, respiratory virus panel nucleic acid assay system, Material Number 07341920190
- Lot codes and dates
- UDI07613336100097
- Serial Numbers
1633316454166881669516871169141704817266199241809418323183571711617086
- Amount recalled
- 14 units
Where it was sold
Why it was recalled
Roche has identified a small number of cobas Liat analyzer units that have consistently high noise levels (background signal) originating from the amber detector (used for Influenza B detection). This noise increases the probability of false positive Influenza B results.
This product could cause temporary or reversible health problems — stop using it.
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