Siemens Healthcare Diagnostics, Inc. recalls Analyzer and Atellica IM 1600 Analyzer system for in vitro diagnostic testing of clinical specimens.
- Recall date
- February 26, 2018
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-1588-2018
- FDA classification
- Class II
- Brand / firm
- Siemens Healthcare Diagnostics, Inc.
- Sold / distributed
- FL and France Spain Sweden United Kingdom Germany
Why it was recalled
When more than one immunoassay analyzer is connected to a single solution system, reporting and conversion factors may not be applied to all analyzers
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
Analyzer and Atellica IM 1600 Analyzer system for in vitro diagnostic testing of clinical specimens.
Get recall alerts
Free email alert whenever Siemens Healthcare Diagnostics, Inc. has a new recall — straight from official government data. Unsubscribe anytime.
More recalls from: Siemens Healthcare Diagnostics, Inc.