Z-0193-2019Class II

Atellica IM 1600 Analyzer (SMN 11066000). The Atellica" Solution is a multi-component system for in vitro...

Name: Z-0193-2019 Atellica IM 1600 Analyzer (SMN 11066000). The Atellica" Solution is a multi-component system for in vitro...
Creator: Siemens Healthcare Diagnostics, Inc.
Published: 2018-06-29
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2018-06-29 / Terminated / root cause: software

FDA source

Siemens Healthcare Diagnostics, Inc. began a recall of Atellica IM 1600 Analyzer (SMN 11066000). The Atellica" Solution is a multi-component system for in vitro diagnostic testing of clinical specimens on 2018-06-29. FDA classified it as Class II and gives the reason as "Atellica Solution system software (SW) version 1.13 and lower, five (5) behavioral issues were identified: 1. Reagent Lock may not work as intended with Primary Reagent ReadyPacks and Ancillary Packs when more than one...". 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-0193-2019
Classification: Class II
Status: Terminated
Initiated: 2018-06-29
Posted: 2018-10-18
Terminated: 2021-08-12
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Atellica IM 1600 Analyzer (SMN 11066000). The Atellica" Solution is a multi-component system for in vitro diagnostic testing of clinical specimens.
Product code: JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Reason for recall: Atellica Solution system software (SW) version 1.13 and lower, five (5) behavioral issues were identified: 1. Reagent Lock may not work as intended with Primary Reagent ReadyPacks and Ancillary Packs when more than one (1) lot of specific Reagent kits are loaded on the analyzer at the same time. 2. Sample barcodes may be incorrectly read 3. The Atellica IM 1300 Analyzer and Atellica IM 1600 Analyzer may not run CEA dilutions at 50x and 100x. The Analyzer may post a Sample Integrity Error when 50x or 100x dilutions are ordered for Carcinoembryonic Antigen (CEA). Dilution factors lower than 50x and neat samples are not affected by this behavior. 4. The Atellica CH 930 Analyzer may continue to display the default reporting units after the reporting units have been changed. 5. The Atellica CH 930 Analyzer may not display results for sample if certain assays are configured to auto-dilute results above or below the assay measuring interval.
Root cause tag: software
FDA root cause: Software design
Action: Siemens issued an Urgent medical Device Correction, (UMDC ASW18-02.A.US) and Urgent Field Safety Notification (UFSN ASW18-02.A.OUS) on 6/29/18, via FedEx to the US Customer and via email distribution to countries Outside US (OUS). The field action letters explain the behaviors and informed Customers of action to be taken to prevent the behaviors from occurring. Siemens has released an updated software (SW) version (V), 1.14, which corrects the reported behaviors.
Quantity in commerce: 92
Distribution: Nationwide Foreign: Australia Austria Belgium Brazil Canada Croatia Czech Republic Denmark France Germany Greece Italy Japan Malaysia Mexico Netherlands Norway Poland Republic Korea Singapore Spain Sweden Switzerland U.A.E. United Kingdom
Product codes and lots: Software (SW) version 1.13 and lower

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0193-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0189-2019	Class II	Terminated	Voluntary: Firm initiated	2018-10-24	2018-10-18
Z-0190-2019	Class II	Terminated	Voluntary: Firm initiated	2018-10-24	2018-10-18
Z-0191-2019	Class II	Terminated	Voluntary: Firm initiated	2018-10-24	2018-10-18
Z-0192-2019	Class II	Terminated	Voluntary: Firm initiated	2018-10-24	2018-10-18
Z-0193-2019	Class II	Terminated	Voluntary: Firm initiated	2018-10-24	2018-10-18
Z-0194-2019	Class II	Terminated	Voluntary: Firm initiated	2018-10-24	2018-10-18

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)