Z-0204-2020Class II

Atellica IM 1300 Analyzer, (SW) version V1.19.0 and V1.19.2 Siemens Material Number (SMN): 11066001

Name: Z-0204-2020 Atellica IM 1300 Analyzer, (SW) version V1.19.0 and V1.19.2 Siemens Material Number (SMN): 11066001
Creator: Siemens Healthcare Diagnostics, Inc.
Published: 2019-08-15
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2019-08-15 / Terminated

FDA source

Siemens Healthcare Diagnostics, Inc. began a recall of Atellica IM 1300 Analyzer, (SW) version V1.19.0 and V1.19.2 Siemens Material Number (SMN): 11066001 on 2019-08-15. FDA classified it as Class II and gives the reason as "Issues Scanning New Reagent Lot Test Definition on the Atellica IM 1300 Analyzer and Atellica IM 1600 Analyzer SW V 1.19.0 and 1.19.2". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0204-2020
Classification: Class II
Status: Terminated
Initiated: 2019-08-15
Posted: 2019-10-24
Terminated: 2022-05-05
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Atellica IM 1300 Analyzer, (SW) version V1.19.0 and V1.19.2 Siemens Material Number (SMN): 11066001
Product code: JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Reason for recall: Issues Scanning New Reagent Lot Test Definition on the Atellica IM 1300 Analyzer and Atellica IM 1600 Analyzer SW V 1.19.0 and 1.19.2
FDA root cause: Under Investigation by firm
Action: Siemens issued an Urgent Medical Device Correction (UMDC) to US customers via FedEx on August 15, 2019. The UFSN was electronically issued to all OUS Siemens sites, with affected customers, for distribution, as well as regional reporting to their respective local competent authority on August 16, 2019. The UMDC/UFSN explain the behavior(s) to users and provide actions to be taken to correct the behavior. Customers are requested to return the Effectiveness Check Form, in the UMDC/UFSN via fax or email. Siemens Healthcare Diagnostics Inc. has released an updated software (SW) version (V) 1.20.0, which corrects the reported behavior(s). A Mandatory Update (MU) campaign has been launched to install the new SW V on all systems, whether or not they are impacted by these behaviors.
Quantity in commerce: 88 total US: 54;OUS 34
Distribution: Nationwide Foreign: Argentina Australia Bangladesh Belgium Brazil Colombia Dominican Republic Finland France Germany Greece Italy Japan Latvia Mexico Netherlands P.R. China Republic Korea Singapore Spain Switzerland Thailand United Kingdom Vietnam
Product codes and lots: (SW) version V1.19.0 and V1.19.2 UDI: 00630414007960

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0204-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0204-2020	Class II	Terminated	Voluntary: Firm initiated	2019-10-30	2019-10-24
Z-0205-2020	Class II	Terminated	Voluntary: Firm initiated	2019-10-30	2019-10-24

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)