Z-2438-2020Class II

(1) Atellica Data Manager software version 1.0 Siemens Material Number (SMN): 11314237 (2) Atellica Data...

Name: Z-2438-2020 (1) Atellica Data Manager software version 1.0 Siemens Material Number (SMN): 11314237 (2) Atellica Data...
Creator: Siemens Healthcare Diagnostics, Inc.
Published: 2020-05-15
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2020-05-15 / Terminated / root cause: software

FDA source

Siemens Healthcare Diagnostics, Inc. began a recall of (1) Atellica Data Manager software version 1.0 Siemens Material Number (SMN): 11314237 (2) Atellica Data Manager software version 1.1 Siemens Material Number... on 2020-05-15. FDA classified it as Class II and gives the reason as "Unexpected interface driver behavior identified (QC) Results May Be Assigned to an Incorrect Control Lot Number, and lead to the reporting of erroneous patient results if the QC failed but appeared to be passing and the...". 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-2438-2020
Classification: Class II
Status: Terminated
Initiated: 2020-05-15
Posted: 2020-06-26
Terminated: 2021-05-18
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: (1) Atellica Data Manager software version 1.0 Siemens Material Number (SMN): 11314237 (2) Atellica Data Manager software version 1.1 Siemens Material Number (SMN): 11316888 Product Usage: are clinical laboratory information modules which consolidate test orders and test results, provide test ordering and priority routing information to automation, apply rules to test orders and auto-verification rules for test results, and provide integrated management of quality control of test system.
Product code: N/A
Reason for recall: Unexpected interface driver behavior identified (QC) Results May Be Assigned to an Incorrect Control Lot Number, and lead to the reporting of erroneous patient results if the QC failed but appeared to be passing and the issue is not detected during QC review
Root cause tag: software
FDA root cause: Software design
Action: Siemens issued an Urgent Medical device Correction (UMDC ISW-20-01.A.US) and Urgent Field Safety Notification (UFSN ISW-20-01.A.OUS) to affected Customers via overnight mail on 5/15/20. The UMDC ISW 20-01.A.US and UFSN ISW-20-01. Letter states reason for recall, health risk and action to take: Manually Review QC results in CentraLink/Atellica DM daily; Review this letter with your Medical Director. If your laboratory may be affected by this issue based on the conditions listed above, you may consider the following steps to avoid this issue from occurring until Siemens updates your driver: Do not process QC while the interface communication is interrupted Use the Control lot number as the Control ID. Customers were requested to respond via the attached effectiveness check form to indicate receipt and understanding of the letter. Siemens will contact all affected customers to schedule a date to update the interface driver to version 1.5.1, which prevents the issue fromoccurring.
Quantity in commerce: 70 units
Distribution: Worldwide distribution - US Nationwide distribution and the countries of Argentina, Australia, Bahamas, Belgium, Brazil, Chile, Colombia, Czech Republic, Egypt, Germany, Greece, Hungary, India, Italy, Kuwait, Latvia, Lithuania, Malaysia, Mexico, Oman, Peru, Poland, Portugal, Qatar, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Thailand, Turkey, United Arab Emirates, United Kingdom.
Product codes and lots: Software versions: Atellica¿ Data Manager software version 1.0 UDI: 00630414234946 Atellica¿ Data Manager software version 1.1 UDI: 006304142790

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2438-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2437-2020	Class II	Terminated	Voluntary: Firm initiated	2020-07-08	2020-06-26
Z-2438-2020	Class II	Terminated	Voluntary: Firm initiated	2020-07-08	2020-06-26

Product code N/A

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)