The Recall Desk
ModerateFDA (Devices)·Z-0191-2019·Announced 2018-10-24

Siemens Atellica Sample Handler Software Recall for Diagnostic Errors

Siemens Healthcare Diagnostics is recalling Atellica Sample Handler software versions 1.13 and lower due to five behavioral issues that may cause incorrect sample processing or result reporting.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, and the source text describes software behavioral issues that may lead to incorrect diagnostic results or sample handling errors, but does not report any hospitalizations, serious injuries, or deaths.

Plain-English summary

Siemens Healthcare Diagnostics, Inc. is recalling five (5) units of the Atellica Sample Handler Additional (SMN 11069004) software, version 1.13 and lower. The Atellica Solution is a multi-component system used for in vitro diagnostic testing of clinical specimens. The recall is due to the identification of five specific behavioral issues in the software.

The identified issues include: 1) The Reagent Lock may not function as intended when multiple lots of specific reagent kits are loaded simultaneously; 2) Sample barcodes may be incorrectly read; 3) The Atellica IM 1300 and 1600 Analyzers may not run CEA dilutions at 50x and 100x, potentially posting a 'Sample Integrity Error'; 4) The Atellica CH 930 Analyzer may continue to display default reporting units even after they have been changed; and 5) The Atellica CH 930 Analyzer may not display results for samples if certain assays are configured to auto-dilute results outside the assay measuring interval.

The affected software was distributed nationwide and in foreign countries including 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., and the United Kingdom. Users of the Atellica Solution system should contact Siemens Healthcare Diagnostics for further instructions on software updates or remediation.

The recalled product

Product
Atellica Sample Handler Additional (SMN 11069004). The Atellica" Solution is a multi-component system for in vitro diagnostic testing of clinical specimens.
Manufacturer
Siemens Healthcare Diagnostics, Inc.
Category
Medical Device — In Vitro Diagnostic Software
Hazard
Affected units
5

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Software (SW) version 1.13 and lower

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 6 recalled by Siemens Healthcare Diagnostics, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 6 products in this recall →

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