Z-1588-2018 Class II Terminated
FDA device recall Z-1588-2018 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
Analyzer and Atellica IM 1600 Analyzer system 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 00630414002026
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1588-2018
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026