cobas Liat Analyzer recall
cobas Liat Analyzer, for in vitro diagnostic use.
Why was cobas Liat Analyzer 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Production Identifier (Lot/Serial Number): M1-E-00375, M1-E-00380, M1-E-00381, M1-E-00382, M1-E-00389
- Product
- cobas Liat Analyzer, for in vitro diagnostic use.
- Recalling firm
- Roche Molecular Systems, Inc.
- Quantity
- 5 pieces
- Distribution
- US Distribution to the states of :TX and NC.
- Recall date
- September 9, 2015
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)