Z-1586-2018 Class II Terminated
FDA device recall Z-1586-2018 was initiated by Siemens Healthcare Diagnostics, Inc. on Feb 26, 2018 and is designated Class II. Reason for recall: When more than one immunoassay analyzer is connected to a single solution system, reporting and conversion factors may not be applied to all analyzers The recall status is terminated (terminated May 12, 2020).
Recall Details
- Product Type
- Devices
- Report Date
- May 9, 2018
- Initiation Date
- Feb 26, 2018
- Termination Date
- May 12, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
Product Description
Atelia IM 1300 Analyzer for in vitro diagnostic testing of clinical specimens.
Reason for Recall
When more than one immunoassay analyzer is connected to a single solution system, reporting and conversion factors may not be applied to all analyzers
Distribution Pattern
FL and France Spain Sweden United Kingdom Germany
Code Information
UDI 00630414007960
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1586-2018
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026