FDAFDA · Food and drugs·Recall number Z-1588-2018
Analyzer and Atellica IM 1600 Analyzer system for in vitro diagnostic testing of clinical specimens.
Published May 9, 2018 · Recall initiated: February 26, 2018
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
When more than one immunoassay analyzer is connected to a single solution system, reporting and conversion factors may not be applied to all analyzers
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Distributor
- FL and France Spain Sweden United Kingdom Germany
- Lot
- UDI 00630414002026
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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