Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Atellica IM 1300 Analyzer - In vitro diagnostic testing of Recalled by Siemens Healthcare Diagnostics, Inc. Due to Multiple issues in Software v1.23.2 and lower-may lead...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Siemens Healthcare Diagnostics, Inc. directly.
Affected Products
Atellica IM 1300 Analyzer - In vitro diagnostic testing of clinical specimens. Product Siemens Material Number (SMN): 11066001 - Product Usage: intended for the qualitative and quantitative analysis of various body fluids, using photometric, turbidimetric, chemiluminescent, and integrated ion selective electrode technology for clinical use.
Quantity: 1095 units
Why Was This Recalled?
Multiple issues in Software v1.23.2 and lower-may lead to the reporting of discrepant patient results
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Siemens Healthcare Diagnostics, Inc.
Siemens Healthcare Diagnostics, Inc. has 452 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report