Device product

Atelia IM 1300 Analyzer for in vitro diagnostic testing of clinical specimens.

Z-1586-2018

February 26, 2018

Class II

Product summary

Firm: Siemens Healthcare Diagnostics, Inc.
Event: Event 79683
Status: Terminated
Classification: Class II
Quantity: N/A
Official record key: device-enforcement:Z-1586-2018

Official wording

Reason: When more than one immunoassay analyzer is connected to a single solution system, reporting and conversion factors may not be applied to all analyzers

Code information: UDI 00630414007960

Distribution pattern: FL and France Spain Sweden United Kingdom Germany

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

When more than one immunoassay analyzer is connected to a single solution system, reporting and conversion factors may not be applied to all analyzers