Z-1588-2018Class II

Analyzer and Atellica IM 1600 Analyzer system for in vitro diagnostic testing of clinical specimens

Name: Z-1588-2018 Analyzer and Atellica IM 1600 Analyzer system for in vitro diagnostic testing of clinical specimens
Creator: Siemens Healthcare Diagnostics, Inc.
Published: 2018-02-26
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2018-02-26 / Terminated / root cause: software

FDA source

Siemens Healthcare Diagnostics, Inc. began a recall of Analyzer and Atellica IM 1600 Analyzer system for in vitro diagnostic testing of clinical specimens on 2018-02-26. FDA classified it as Class II and gives the reason as "When more than one immunoassay analyzer is connected to a single solution system, reporting and conversion factors may not be applied to all analyzers". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1588-2018
Classification: Class II
Status: Terminated
Initiated: 2018-02-26
Posted: 2018-05-01
Terminated: 2020-05-12
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Analyzer and Atellica IM 1600 Analyzer system for in vitro diagnostic testing of clinical specimens.
Product code: JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
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
Root cause tag: software
FDA root cause: Software design
Action: Recall initiated 02/23/2018 Firm released an update software (SW) version (V), 1.12.1, which corrects the behavior. A Mandatory Update (MU) campaign was launched to install the new SW V on all systems, whether or not they are impacted by this behavior. The MU campaign will be tracked to 100% completion globally.
Distribution: FL and France Spain Sweden United Kingdom Germany
Product codes and lots: UDI 00630414002026

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1588-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1586-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-09	2018-05-01
Z-1587-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-09	2018-05-01
Z-1588-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-09	2018-05-01

Product code JJE

K151792Class IITrinidad IM Thyroid Stimulating Hormone (TSH) Assay, Trinidad IM TSH Calibrators, Trinidad Immunoassay (IM) SystemSiemens Healthcare Diagnostics, Inc. / cleared 2015-11-20

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)