FDAFDA · Food and drugs·Recall number Z-2216-2016
cobas¿ Liat¿ Analyzer
Published July 27, 2016 · Recall initiated: May 9, 2016
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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 to do
Voluntary: Firm initiated · Telephone
Recall details
- Manufacturer
- Roche Molecular Systems, Inc.
- Distributor
- Distributed in NC and WA.
- Lot
- US-IVD: M1-E-00383 & M1-E-00434
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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