cobas¿ Liat¿ Analyzer recall
cobas¿ Liat¿ Analyzer
Why was cobas¿ Liat¿ Analyzer recalled?
Device was released with default pcal/gain settings for photometers instead of the pcal/gain settings that are required for release. The default settings can potentially lead to the generation of erroneous or invalid results.
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?
US-IVD: M1-E-00383 & M1-E-00434
- Product
- cobas¿ Liat¿ Analyzer
- Recalling firm
- Roche Molecular Systems, Inc.
- Quantity
- 2
- Distribution
- Distributed in NC and WA.
- Recall date
- July 27, 2016
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)