Reported Sep 9, 2015 · Terminated
cobas Liat Analyzer, for in vitro diagnostic use.
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 Liat Analyzer, for in vitro diagnostic use.
- Lot codes and dates
- Production
- Identifier (Lot/Serial Number)
M1-E-00375M1-E-00380M1-E-00381M1-E-00382M1-E-00389
- Amount recalled
- 5 pieces
Where it was sold
Why it was recalled
Due to a supplier issue, the incorrect green and amber LED components were used in the manufacture of the LED printed circuit board assemblies (PCBA) in certain cobas Liat Analyzers.
This product could cause temporary or reversible health problems — stop using it.
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