Siemens Recalls Atellica IM 1600 Analyzer Software Due to Behavioral Issues
Siemens Healthcare Diagnostics is recalling Atellica IM 1600 Analyzer software version 1.13 and lower due to five identified behavioral issues affecting reagent locking, barcode reading, and result reporting.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II and involves a medical device where software errors could lead to incorrect diagnostic results or sample handling errors, representing a risk of harm where injury has not yet been reported.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling 92 units of the Atellica IM 1600 Analyzer (SMN 11066000) equipped with 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 voluntary and is classified as Class II by the U.S. Food and Drug Administration.
The recall was initiated because five behavioral issues were identified in the system software. These issues include the Reagent Lock potentially not working as intended when multiple lots of specific reagent kits are loaded, sample barcodes potentially being incorrectly read, and the analyzer potentially failing to run specific Carcinoembryonic Antigen (CEA) dilutions at 50x and 100x. Additionally, the Atellica CH 930 Analyzer may display default reporting units after changes or may not display results for samples with certain auto-dilution configurations.
The affected units were 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. Healthcare facilities using these analyzers should contact Siemens Healthcare Diagnostics for instructions on how to update the software or resolve the issues.
The recalled product
- Product
- Atellica IM 1600 Analyzer (SMN 11066000). The Atellica" Solution is a multi-component system for in vitro diagnostic testing of clinical specimens.
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Affected units
- 92
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.
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